1,711 results on '"Richter, Holly E."'
Search Results
2. Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial
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Stanley, Russell F., Meyer, Isuzu, Blanchard, Christina T., and Richter, Holly E.
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- 2024
- Full Text
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3. First and Second Stage Risk Factors Associated with Perineal Lacerations
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Saucedo, Alexander M., Tuuli, Methodius G., Gregory, W. Thomas, Richter, Holly E., Lowder, Jerry L., Woolfolk, Candice, Caughey, Aaron B., Srinivas, Sindhu K., Tita, Alan T. N., Macones, George A., and Cahill, Alison G.
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- 2024
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4. Dietary Intake and Symptom Severity in Women with Fecal Incontinence
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Andy, Uduak U., Iriondo-Perez, Jeniffer, Carper, Benjamin, Richter, Holly E., Dyer, Keisha Y., Florian-Rodriguez, Maria, Napoe, G. Sarah, Myers, Deborah, O’Shea, Michele, Mazloomdoost, Donna, and Gantz, Marie G.
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- 2024
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5. Post-Obstetric Fistula Repair Urinary Leakage: A Need for Patient Education, Research and Innovation to Achieve Evidence-Based Management
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Richter, Holly E., Ouédraogo, Itengré, and Nardos, Rahel
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- 2024
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6. A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months
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Weinstein, Milena M., Dunivan, Gena C., Guaderrama, Noelani M., and Richter, Holly E.
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- 2024
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- View/download PDF
7. Five-year surgical outcomes of transvaginal apical approaches in women with advanced pelvic organ prolapse
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Meyer, Isuzu, Blanchard, Christina T., Szychowski, Jeff M., and Richter, Holly E.
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- 2023
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8. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.
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Zyczynski, Halina M, Richter, Holly E, Sung, Vivian W, Lukacz, Emily S, Arya, Lily A, Rahn, David D, Visco, Anthony G, Mazloomdoost, Donna, Carper, Benjamin, Gantz, Marie G, and NICHD Pelvic Floor Disorders Network
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NICHD Pelvic Floor Disorders Network ,Tibial Nerve ,Humans ,Fecal Incontinence ,Transcutaneous Electric Nerve Stimulation ,Single-Blind Method ,Quality of Life ,Aged ,Middle Aged ,Female ,Clinical Research ,Clinical Trials and Supportive Activities ,Digestive Diseases ,Oral and gastrointestinal ,Clinical Sciences ,Gastroenterology & Hepatology - Abstract
IntroductionTo determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments.MethodsWomen aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model.ResultsOf 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group.DiscussionAlthough symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.
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- 2022
9. Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence
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Richter, Holly E, Carnes, Megan U, Komesu, Yuko M, Lukacz, Emily S, Arya, Lily, Bradley, Megan, Rogers, Rebecca G, Sung, Vivian W, Siddiqui, Nazema Y, Carper, Benjamin, Mazloomdoost, Donna, Dinwiddie, Darryl, Gantz, Marie G, and Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Aging ,Urologic Diseases ,Clinical Research ,Female ,Humans ,Lactobacillus ,Microbiota ,Middle Aged ,Suburethral Slings ,Treatment Outcome ,Urinary Incontinence ,Urinary Tract ,Vagina ,midurethral sling procedure ,mixed urinary incontinence ,surgical outcomes ,urinary microbiome ,vaginal microbiome ,Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine - Abstract
BackgroundThe urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence.ObjectiveThis study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence.Study designThis cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models.ResultsObjective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P
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- 2022
10. Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.
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Zyczynski, Halina M, Arya, Lily A, Lukacz, Emily S, Richter, Holly E, Rahn, David D, Sung, Vivian W, Visco, Anthony G, Shaffer, Amanda, Jelovsek, J Eric, Rogers, Rebecca, Mazloomdoost, Donna, Gantz, Marie G, and Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN)
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Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network ,Tibial Nerve ,Humans ,Fecal Incontinence ,Treatment Outcome ,Transcutaneous Electric Nerve Stimulation ,Quality of Life ,Female ,Digestive Diseases ,Clinical Research ,Clinical Trials and Supportive Activities ,Comparative Effectiveness Research ,Oral and gastrointestinal ,fecal incontinence ,accidental bowel leakage ,percutaneous tibial nerve stimulation ,posterior tibial nerve stimulation ,neuromodulation ,sham electrical stimulation ,randomized controlled trial - Abstract
ObjectivesHigh-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage.MethodsThe rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function.ResultsSample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks.ConclusionsThe methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.
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- 2021
11. Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria
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Bowen, Shaniel T, Moalli, Pamela A, Abramowitch, Steven D, Lockhart, Mark E, Weidner, Alison C, Ferrando, Cecile A, Nager, Charles W, Richter, Holly E, Rardin, Charles R, Komesu, Yuko M, Harvie, Heidi S, Mazloomdoost, Donna, Sridhar, Amaanti, Gantz, Marie G, Albo, Michael E, Alperin, Marianna, Columbo, Joann, Curry, Jodi, Ferrante, Kimberly, Herrala, Kyle, Johnson, Sherella, Kirby, Anna C, Lukacz, Emily S, Ruppert, Erika, Wasenda, Erika, Diwadkar, Gouri B, Dyer, Keisha Y, Mackinnon, Linda M, Menefee, Shawn A, Tan-Kim, Jasmine, Zazueta-Damian, Gisselle, Amundsen, Cindy, Bruton, Yasmeen, Coleman-Taylor, Notorious, Gilliam, Robin, Harris, Acacia, Hayes, Akira, Kawasaki, Amie, Longoria, Nicole, McLean, Shantae, Raynor, Mary, Siddiqui, Nazema, Visco, Anthony G, Ballard, Alicia, Carter, Kathy, Ellington, David, Patel, Sunita, Saxon, Nancy, Varner, R Edward, Willis, Velria, Carberry, Cassandra, Douglas, Samantha, Hampton, B Star, Korbly, Nicole, Meers, Ann S, Myers, Deborah L, Sung, Vivian W, Viscione, Elizabeth-Ann, Wohlrab, Kyle, Box, Karen, Dunivan, Gena, Jeppson, Peter, Middendorf, Julia, Rogers, Rebecca G, Arya, Lily, Andy, Uduak, Butler, Norman, Cain, Doris, Carney, Teresa, Flick, Lorraine, Khanijow, Kavita Desai, Kingslee, Michelle, Lee, Daniel, O’Donnell, Patricia, Smith, Ariana, Thompson, Donna, Bonidie, Michael, Gruss, Judy, Lowder, Jerry, Shepherd, Jonathan, Sutkin, Gary, Zyczynski, Halina M, Barber, Matthew, Dastoli, Kathleen, Edington, Maryori, Graham, Annette, Krishnan, Geetha, Jelovsek, Eric, Paraiso, Marie Fidela R, Pung, Ly, Ferrando, Cecile, Walters, Mark, Meikle, Susan, Burd, Andrew, Burdekin, Kate, Glass, Kendra, Grant, Tracey, and Grey, Scott
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Clinical Research ,Clinical Trials and Supportive Activities ,Aged ,Female ,Gynecologic Surgical Procedures ,Humans ,Hysterectomy ,Vaginal ,Imaging ,Three-Dimensional ,Magnetic Resonance Imaging ,Middle Aged ,Pelvis ,Recurrence ,Treatment Failure ,Uterine Prolapse ,hysteropexy ,magnetic resonance imaging ,pelvic organ prolapse ,prolapse surgery ,transvaginal mesh ,vaginal hysterectomy ,Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine - Abstract
BackgroundProlapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies.ObjectiveThis study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse.Study designThis multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests.ResultsOf the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15).ConclusionThe primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.
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- 2021
12. Open Abdominal Approach to Supporting the Vaginal Apex
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Stanley, Russell, primary, Powell, T. Clark, additional, and Richter, Holly E., additional
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- 2023
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13. Performance, acceptability, and validation of a phone application bowel diary
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Zyczynski, Halina M, Richter, Holly E, Sung, Vivian W, Arya, Lily A, Lukacz, Emily S, Visco, Anthony G, Rahn, David D, Carper, Benjamin, Mazloomdoost, Donna, Gantz, Marie G, and Network, for the NICHD Pelvic Floor Disorders
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Biomedical and Clinical Sciences ,Clinical Sciences ,Digestive Diseases ,Clinical Trials and Supportive Activities ,Clinical Research ,Aged ,Aged ,80 and over ,Cross-Over Studies ,Data Collection ,Defecation ,Fecal Incontinence ,Female ,Humans ,Middle Aged ,Reproducibility of Results ,Telephone ,accidental bowel leakage ,Bowel eDiary ,electronic bowel diary ,fecal incontinence ,phone application diary ,NICHD Pelvic Floor Disorders Network ,Neurosciences ,Urology & Nephrology ,Clinical sciences - Abstract
AimsTo assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).MethodsWomen reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).ResultsPaired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.ConclusionThe PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.
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- 2020
14. Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence
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Meyer, Isuzu, Whitworth, Ryan E, Lukacz, Emily S, Smith, Ariana L, Sung, Vivian W, Visco, Anthony G, Ackenbom, Mary F, Wai, Clifford Y, Mazloomdoost, Donna, Gantz, Marie G, and Richter, Holly E
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Research ,Urologic Diseases ,Reproductive health and childbirth ,Renal and urogenital ,Female ,Gynecologic Surgical Procedures ,Humans ,Pelvic Organ Prolapse ,Suburethral Slings ,Treatment Outcome ,Urinary Incontinence ,Stress ,Uterine Prolapse ,Advanced prolapse ,Pelvic organ prolapse ,Prolapse repair ,Sacrospinous ligament fixation ,Uterosacral ligament suspension ,Vaginal prolapse repair ,NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women’s Health ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine ,Midwifery - Abstract
Introduction and hypothesisLimited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.MethodsThis was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.ResultsSuccess did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.ConclusionsSurgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.
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- 2020
15. Defining the relationship between vaginal and urinary microbiomes
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Komesu, Yuko M, Dinwiddie, Darrell L, Richter, Holly E, Lukacz, Emily S, Sung, Vivian W, Siddiqui, Nazema Y, Zyczynski, Halina M, Ridgeway, Beri, Rogers, Rebecca G, Arya, Lily A, Mazloomdoost, Donna, Levy, Josh, Carper, Benjamin, Gantz, Marie G, and Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Urologic Diseases ,Infectious Diseases ,Renal and urogenital ,Adult ,Burkholderiales ,Case-Control Studies ,Clostridiales ,Discriminant Analysis ,Escherichia ,Female ,Flavobacterium ,Gardnerella ,Humans ,Lactobacillus ,Linear Models ,Microbiota ,Middle Aged ,Prevotella ,RNA ,Ribosomal ,16S ,Streptococcus ,Ureaplasma ,Urinary Incontinence ,Urinary Tract ,Urine ,Vagina ,mixed urinary incontinence ,urinary microbiome ,urologic conditions ,vaginal microbiome ,Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine - Abstract
BackgroundAlthough the vaginal and urinary microbiomes have been increasingly well-characterized in health and disease, few have described the relationship between these neighboring environments. Elucidating this relationship has implications for understanding how manipulation of the vaginal microbiome may affect the urinary microbiome and treatment of common urinary conditions.ObjectiveTo describe the relationship between urinary and vaginal microbiomes using 16S rRNA gene sequencing. We hypothesized that the composition of the urinary and vaginal microbiomes would be significantly associated, with similarities in predominant taxa.Study designThis multicenter study collected vaginal swabs and catheterized urine samples from 186 women with mixed urinary incontinence enrolled in a parent study and 84 similarly aged controls. Investigators decided a priori that if vaginal and/or urinary microbiomes differed between continent and incontinent women, the groups would be analyzed separately; if similar, samples from continent and incontinent women would be pooled and analyzed together. A central laboratory sequenced variable regions 1-3 (v1-3) and characterized bacteria to the genus level. Operational taxonomic unit abundance was described for paired vaginal and urine samples. Pearson's correlation characterized the relationship between individual operational taxonomic units of paired samples. Canonical correlation analysis evaluated the association between clinical variables (including mixed urinary incontinence and control status) and vaginal and urinary operational taxonomic units, using the Canonical correlation analysis function in the Vegan package (R version 3.5). Linear discriminant analysis effect size was used to find taxa that discriminated between vaginal and urinary samples.ResultsUrinary and vaginal samples were collected from 212 women (mean age 53±11 years) and results from 197 paired samples were available for analysis. As operational taxonomic units in mixed urinary incontinence and control samples were related in canonical correlation analysis and since taxa did not discriminate between mixed urinary incontinence or controls in either vagina or urine, mixed urinary incontinence and control samples were pooled for further analysis. Canonical correlation analysis of vaginal and urinary samples indicated that that 60 of the 100 most abundant operational taxonomic units in the samples largely overlapped. Lactobacillus was the most abundant genus in both urine and vagina (contributing on average 53% to an individual's urine sample and 64% to an individual's vaginal sample) (Pearson correlation r=0.53). Although less abundant than Lactobacillus, other bacteria with high Pearson correlation coefficients also commonly found in vagina and urine included: Gardnerella (r=0.70), Prevotella (r=0.64), and Ureaplasma (r=0.50). Linear discriminant analysis effect size analysis identified Tepidimonas and Flavobacterium as bacteria that distinguished the urinary environment for both mixed urinary incontinence and controls as these bacteria were absent in the vagina (Tepidimonas effect size 2.38, P
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- 2020
16. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery Versus Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial
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Sung, Vivian W, Borello-France, Diane, Newman, Diane K, Richter, Holly E, Lukacz, Emily S, Moalli, Pamela, Weidner, Alison C, Smith, Ariana L, Dunivan, Gena, Ridgeway, Beri, Nguyen, John N, Mazloomdoost, Donna, Carper, Benjamin, and Gantz, Marie G
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Renal and urogenital ,Reproductive health and childbirth ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine - Published
- 2020
17. Effect of Vaginal Mesh Hysteropexy Versus Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial
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Nager, Charles W, Visco, Anthony G, Richter, Holly E, Rardin, Charles R, Rogers, Rebecca G, Harvie, Heidi S, Zyczynski, Halina M, Paraiso, Marie Fidela R, Mazloomdoost, Donna, Grey, Scott, Sridhar, Amaanti, and Wallace, Dennis
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Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine - Published
- 2020
18. Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse
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Strohbehn, Kris, Wadensweiler, Paul M., Richter, Holly E., Grimes, Cara L., Rardin, Charles R., Rosenblatt, Peter L., Toglia, Marc R., Siddiqui, Gazala, and Hanissian, Paul
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- 2024
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19. Patient perspectives in adverse event reporting after vaginal apical prolapse surgery
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Sung, Vivian W., Menefee, Shawn, Richter, Holly E., Moalli, Pamela A., Andy, Uduak, Weidner, Alison, Rahn, David D., Paraiso, Marie F., Jeney, Sarah E., Mazloomdoost, Donna, Gilbert, Jace, Whitworth, Ryan, and Thomas, Sonia
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- 2024
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20. Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair
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Rahn, David D., Richter, Holly E., Sung, Vivian W., and Pruszynski, Jessica E.
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- 2024
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21. Challenges and New Insights in the Management of Urinary Incontinence in Older Women
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Meyer, Isuzu and Richter, Holly E.
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- 2022
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22. Intrapartum risk factors associated with pelvic organ prolapse at 6 months postpartum
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Saucedo, Alexander M., Richter, Holly E., Gregory, W. Thomas, Woolfolk, Candice, Tuuli, Methodius G., Lowder, Jerry L., Caughey, Aaron B., Srinivas, Sindhu K., Tita, Alan T.N., Macones, George A., and Cahill, Alison G.
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- 2022
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23. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.
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Sung, Vivian W, Borello-France, Diane, Newman, Diane K, Richter, Holly E, Lukacz, Emily S, Moalli, Pamela, Weidner, Alison C, Smith, Ariana L, Dunivan, Gena, Ridgeway, Beri, Nguyen, John N, Mazloomdoost, Donna, Carper, Benjamin, and Gantz, Marie G
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Mind and Body ,Rehabilitation ,Urologic Diseases ,Clinical Trials and Supportive Activities ,Clinical Research ,Contraception/Reproduction ,Reproductive health and childbirth ,Renal and urogenital ,Adult ,Combined Modality Therapy ,Exercise Therapy ,Female ,Follow-Up Studies ,Humans ,Middle Aged ,Pelvic Floor ,Suburethral Slings ,Treatment Outcome ,Urinary Incontinence ,Urologic Surgical Procedures ,NICHD Pelvic Floor Disorders Network ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - Abstract
ImportanceMixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.ObjectiveTo determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.Design, setting, and participantsRandomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.InterventionsBehavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).Main outcomes and measuresThe primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.ResultsAmong 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).Conclusions and relevanceAmong women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT01959347.
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- 2019
24. The urinary microbiome in women with mixed urinary incontinence compared to similarly aged controls.
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Komesu, Yuko M, Richter, Holly E, Carper, Benjamin, Dinwiddie, Darrell L, Lukacz, Emily S, Siddiqui, Nazema Y, Sung, Vivian W, Zyczynski, Halina M, Ridgeway, Beri, Rogers, Rebecca G, Arya, Lily A, Mazloomdoost, Donna, Gantz, Marie G, and Pelvic Floor Disorders Network
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Pelvic Floor Disorders Network ,Urinary Tract ,Humans ,Lactobacillus ,Urinary Incontinence ,RNA ,Ribosomal ,16S ,Linear Models ,Case-Control Studies ,Sequence Analysis ,DNA ,Adult ,Middle Aged ,Female ,Microbiota ,Surveys and Questionnaires ,16S rRNA gene sequencing ,Female urinary microbiome ,Menopausal status ,Mixed urinary incontinence ,Urinary microbiome ,Obstetrics & Reproductive Medicine ,Paediatrics and Reproductive Medicine - Abstract
INTRODUCTION & HYPOTHESIS:Previous studies have suggested that women with urinary incontinence have an altered urinary microbiome. We hypothesized that the microbiome in women with mixed urinary incontinence (MUI) differed from controls and tested this hypothesis using bacterial gene sequencing techniques. METHODS:This multicenter study compared the urinary microbiome in women with MUI and similarly aged controls. Catheterized urine samples were obtained; v4-6 regions of the 16S rRNA gene were sequenced to identify bacteria. Bacterial predominance (> 50% of an individual's genera) was compared between MUI and controls. Bacterial sequences were categorized into "community types" using Dirichlet multinomial mixture (DMM) methods. Generalized linear mixed models predicted MUI/control status based on clinical characteristics and community type. Post-hoc analyses were performed in women < 51 and ≥ 51 years. Sample size estimates required 200 samples to detect a 20% difference in Lactobacillus predominance with P
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- 2018
25. Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.
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Menefee, Shawn A., Richter, Holly E., Myers, Deborah, Moalli, Pamela, Weidner, Alison C., Harvie, Heidi S., Rahn, David D., Meriwether, Kate V., Paraiso, Marie Fidela R., Whitworth, Ryan, Mazloomdoost, Donna, and Thomas, Sonia
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- 2024
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26. Special Evidence-Based Considerations in Geriatric Gynecologic Care: Pelvic Floor Disorders
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Norris, Kyle P., Illston, Jana D., Malek, Joseph M., Ellington, David R., Richter, Holly E., Lee, Andrew G., editor, Potter, Jane F., editor, and Harper, G. Michael, editor
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- 2021
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27. Urinary microbiome community types associated with urinary incontinence severity in women
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Carnes, Megan U., Siddiqui, Nazema Y., Karstens, Lisa, Gantz, Marie G., Dinwiddie, Darrell L., Sung, Vivian W., Bradley, Megan, Brubaker, Linda, Ferrando, Cecile A., Mazloomdoost, Donna, Richter, Holly E., Rogers, Rebecca G., Smith, Ariana L., and Komesu, Yuko M.
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- 2024
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28. Association of Pharmacologic Treatment of Urgency Urinary Incontinence With Sleep Quality and Daytime Sleepiness
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Warsi, Qurratul A, Huang, Alison J, Hess, Rachel, Arya, Lily A, Richter, Holly E, Bradley, Catherine S, Rogers, Rebecca G, Myers, Deborah L, Johnson, Karen C, Winkelman, William D, Gregory, W Thomas, Kraus, Stephen R, Schembri, Michael, Brown, Jeanette S, Stone, Katie L, and Subak, Leslee L
- Subjects
Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Research ,Urologic Diseases ,Behavioral and Social Science ,Sleep Research ,Aging ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adult ,Aged ,Benzhydryl Compounds ,Double-Blind Method ,Female ,Humans ,Middle Aged ,Muscarinic Antagonists ,Self Report ,Sleep ,Treatment Outcome ,Urinary Bladder ,Overactive ,Urinary Incontinence ,Urge ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine - Abstract
ObjectiveTo evaluate the association between pharmacologic therapy for urgency urinary incontinence (UUI) and sleep quality.MethodsWe conducted a planned secondary data analysis of sleep outcomes in a previously conducted multicenter, double-blind, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence among community-dwelling women self-diagnosed using the 3-Incontinence Questions questionnaire. Participants (N=645) were assigned randomly to 4-8 mg antimuscarinic therapy daily or placebo. At baseline and 12 weeks, participants completed a validated voiding diary to evaluate incontinence and voiding symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep quality, and the Epworth Sleepiness Scale to evaluate daytime sleepiness.ResultsMean (SD) age was 56 (±14) years, 68% were white, and 57% had poor sleep quality (Pittsburgh Sleep Quality Index score greater than 5). Mean frequency of any urinary incontinence and UUI was 4.6 and 3.9 episodes/d, respectively. After 12 weeks, women randomized to the antimuscarinic group reported greater decrease compared with the placebo group in UUI frequency (0.9 episodes/d; P
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- 2018
29. A Behavioral Weight Loss Program and Nonurinary Incontinence Lower Urinary Tract Symptoms in Overweight and Obese Women with Urinary Incontinence: A Secondary Data Analysis of PRIDE
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Breyer, Benjamin N, Creasman, Jennifer M, Richter, Holly E, Myers, Deborah, Burgio, Kathryn L, Wing, Rena R, West, Delia Smith, Kusek, John W, Subak, Leslee L, and PRIDE
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Biomedical and Clinical Sciences ,Clinical Sciences ,Urologic Diseases ,Prevention ,Nutrition ,Clinical Trials and Supportive Activities ,Clinical Research ,Obesity ,Behavioral and Social Science ,Metabolic and endocrine ,Oral and gastrointestinal ,Renal and urogenital ,Adult ,Behavior Therapy ,Data Analysis ,Exercise ,Female ,Humans ,Middle Aged ,Overweight ,Patient Education as Topic ,Prevalence ,Treatment Outcome ,Urinary Incontinence ,Weight Loss ,Weight Reduction Programs ,urination disorders ,lower urinary tract symptoms ,obesity ,female ,weight loss ,PRIDE ,Urology & Nephrology ,Clinical sciences - Abstract
PurposeWe sought to determine whether a behavioral weight reduction intervention would improve nonurinary incontinence lower urinary tract storage symptoms at 6 months, including urinary frequency, nocturia and urgency, compared to a structured education program serving as the control group among overweight and obese women with urinary incontinence.Materials and methodsPRIDE (Program to Reduce Incontinence by Diet and Exercise) was a randomized clinical trial performed in 338 overweight or obese women with urinary incontinence. Participants were randomized, including 226 to 6-month behavioral weight loss intervention and 112 to the control group. All participants received a self-help behavioral treatment booklet to improve bladder control. On this secondary data analysis we examined changes in nonurinary incontinence lower urinary tract storage symptoms from baseline to 6 months and the impact of treatment allocation (intervention vs control), weight loss and physical activity.ResultsNonurinary incontinence lower urinary tract storage symptoms were common at baseline, varying from 48% to 62%. In the 2 groups combined women experienced significant improvement in nocturia, urgency and International Prostate Symptom Score at 6 months (all p
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- 2018
30. Characterizing the Functional Decline of Older Women With Incident Urinary Incontinence
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Parker-Autry, Candace, Houston, Denise K, Rushing, Julia, Richter, Holly E, Subak, Leslee, Kanaya, Alka M, and Kritchevsky, Stephen B
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Research ,Aging ,Urologic Diseases ,Rehabilitation ,Renal and urogenital ,Musculoskeletal ,Aged ,Female ,Hand Strength ,Humans ,Incidence ,Muscle Strength ,Muscle ,Skeletal ,Odds Ratio ,Postural Balance ,Posture ,Prospective Studies ,Sarcopenia ,Urinary Incontinence ,Vitamin D ,Vitamin D Deficiency ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine - Abstract
ObjectiveTo characterize change in physical performance and differential prevalence of low skeletal muscle mass and strength (sarcopenia) and lower 25-hydroxyvitamin D concentrations among older women who developed urinary incontinence (UI) symptoms.MethodsThis is a secondary analysis of the Health, Aging, and Body Composition Study. Urinary incontinence symptoms were assessed using validated questions. The Short Physical Performance Battery measured physical performance. Sarcopenia, defined by low muscle mass and strength, was determined using validated cutoffs for gait speed, grip strength, and appendicular skeletal muscle mass. All parameters were evaluated at baseline and year 4. Serum 25-hydroxyvitamin D concentrations were assessed at year 2. The primary outcome was change in Short Physical Performance Battery total scores. Sarcopenia and lower serum 25-hydroxyvitamin D concentrations have been independently associated with poor physical performance and UI and were therefore included as secondary outcomes. Univariate and multivariate analyses were used to characterize the associations of change in physical performance from baseline to year 4, incidence of sarcopenia, and lower serum 25-hydroxyvitamin D on the development of UI symptoms.ResultsOf the 1,583 women enrolled, 910 were excluded (730 had baseline UI; 180 with missing data). Six hundred seventy-three women were continent at baseline; 223 (33%) developed UI symptoms at year 4. SPPB total scores significantly declined in women with UI versus continent women (mean difference continent-incident UI 0.32, 95% CI 0.04-0.60, P=.02). Of subscale measures, standing balance showed the greatest decline at 0.20 (0.05-0.36; continent-incident UI, respectively; P=.009). Sarcopenia developed at a higher rate with incident UI (adjusted odds ratio [OR] 1.7, 95% CI 1.0-2.9). Low 25-hydroxyvitamin D was not associated with incident UI (adjusted OR 1.1, 95% CI 0.7-1.6 and 1.1, 95% CI 0.7-1.6 for deficient or insufficient versus sufficient status, respectively).ConclusionWe observed a significant decline in standing balance among older women who developed UI symptoms. This decline may be associated with coinciding development of sarcopenia.
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- 2017
31. 234 Translation of Community Engagement Studios into Practice: Increased Research Participation and Diversity in a Multicenter Trial
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Jeppson, Peter C., primary, Gonzalez, Florencia, additional, Rishel Brakey, Heidi A., additional, Nodora, Jesse, additional, Okoro, Grace, additional, Veera, Sarashwathy, additional, Sanses, Tatiana V. D., additional, Lukacz, Emily S., additional, Richter, Holly E., additional, and Sung, Vivian W., additional
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- 2024
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32. Inhibition of NFAT promotes loss of tissue resident uterine natural killer cells and attendant pregnancy complications in humans
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Asiimwe, Rebecca, primary, Knott, Brittney, additional, Greene, Morgan E., additional, Wright, Emma, additional, Bell, Markayla, additional, Epstein, Daniel, additional, Yates, Stefani D., additional, Cheung, Matthew D., additional, Gonzalez, Michael V., additional, Fry, Samantha, additional, Boydston, Emily, additional, Clevenger, Stephanie, additional, Locke, Jayme E., additional, George, James F., additional, Burney, Richard, additional, Arora, Nitin, additional, Duncan, Virginia E., additional, Richter, Holly E., additional, Gunn, Deidre, additional, Freud, Aharon G., additional, Little, Shawn C., additional, and Porrett, Paige M., additional
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- 2024
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33. Pain Catastrophizing and Impact on Pelvic Floor Surgery Experience
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Powell, T. Clark, primary, Meyer, Isuzu, additional, Redden, David T., additional, Maier, Julia, additional, Nguyen, Christine, additional, and Richter, Holly E., additional
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- 2024
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34. Gynecologic Disorders in the Older Woman
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Meyer, Isuzu, Howard, Tera F., Smith, Haller J., Kim, Kenneth H., Richter, Holly E., Johanning, Jason, Section editor, Lagoo-Deenadayalan, Sandhya, Section editor, Rosenthal, Ronnie A., editor, Zenilman, Michael E., editor, and Katlic, Mark R., editor
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- 2020
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35. Effect of darifenacin on fecal incontinence in women with double incontinence
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Kissane, Lindsay M., Martin, Kimberly D., Meyer, Isuzu, and Richter, Holly E.
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- 2021
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36. Association of Pelvic Organ Prolapse Quantification examination D point with uterosacral ligament suspension outcomes: the “OPTIMAL” D point
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Richter, Lee A., Bradley, Sarah E., Desale, Sameer, Richter, Holly E., Park, Amy J., and Iglesia, Cheryl B.
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- 2021
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37. Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence
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Komesu, Yuko M, Richter, Holly E, Dinwiddie, Darrell L, Siddiqui, Nazema Y, Sung, Vivian W, Lukacz, Emily S, Ridgeway, Beri, Arya, Lily A, Zyczynski, Halina M, Rogers, Rebecca G, and Gantz, Marie
- Subjects
Reproductive Medicine ,Biomedical and Clinical Sciences ,Genetics ,Clinical Research ,Urologic Diseases ,Clinical Trials and Supportive Activities ,Renal and urogenital ,Reproductive health and childbirth ,Female ,Humans ,Microbiota ,Middle Aged ,Polymerase Chain Reaction ,Research Design ,Sequence Analysis ,DNA ,Surveys and Questionnaires ,Urinary Incontinence ,Stress ,Urinary Incontinence ,Urge ,Vagina ,Female urinary microbiome ,Urinary taxa ,Vaginal microbiome ,Mixed urinary incontinence ,Next-generation sequencing ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine ,Midwifery - Abstract
Introduction and hypothesisWe describe the rationale and methods of a study designed to compare vaginal and urinary microbiomes in women with mixed urinary incontinence (MUI) and similarly aged, asymptomatic controls.MethodsThis paper delineates the methodology of a supplementary microbiome study nested in an ongoing randomized controlled trial comparing a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone for MUI. Women in the parent study had at least "moderate bother" from urgency and stress urinary incontinence symptoms (SUI) on validated questionnaire and confirmed MUI on bladder diary. Controls had no incontinence symptoms. All participants underwent vaginal and urine collection for DNA analysis and conventional urine culture. Standardized protocols were designed, and a central lab received samples for subsequent polymerase chain reaction (PCR) amplification and sequencing of the bacterial16S ribosomal RNA (rRNA) gene. The composition of bacterial communities will be determined by dual amplicon sequencing of variable regions 1-3 and 4-6 from vaginal and urine specimens to compare the microbiome of patients with controls. Sample-size estimates determined that 126 MUI and 84 control participants were sufficient to detect a 20 % difference in predominant urinary genera, with 80 % power and 0.05 significance level.ResultsSpecimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation.ConclusionsMethods papers sharing information regarding development of genitourinary microbiome studies, particularly with control populations, are few. We describe the rigorous methodology developed for a novel urogenital microbiome study in women with MUI.
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- 2017
38. Evaluation of the urinary microbiota of women with uncomplicated stress urinary incontinence
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Thomas-White, Krystal J, Kliethermes, Stephanie, Rickey, Leslie, Lukacz, Emily S, Richter, Holly E, Moalli, Pamela, Zimmern, Philippe, Norton, Peggy, Kusek, John W, Wolfe, Alan J, Brubaker, Linda, and Network, Institute of Diabetes and Digestive and Kidney Diseases Urinary Incontinence Treatment
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Urologic Diseases ,Aging ,Clinical Research ,Genetics ,Renal and urogenital ,Actinobacteria ,Adult ,Bacterial Typing Techniques ,Biodiversity ,Body Mass Index ,Corynebacterium ,Cross-Sectional Studies ,DNA ,Bacterial ,Female ,Humans ,Lactobacillus ,Microbiota ,Middle Aged ,Phylogeny ,Prevotella ,RNA ,Ribosomal ,16S ,Randomized Controlled Trials as Topic ,Streptococcus ,Urinary Incontinence ,Stress ,Urine ,bladder ,estrogen ,microbiome ,stress urinary incontinence ,urgency urinary incontinence ,National Institute of Diabetes and Digestive and Kidney Diseases Urinary Incontinence Treatment Network ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine - Abstract
BackgroundFemale urinary microbiota are associated with urgency urinary incontinence and response to medication. The urinary microbiota of women with stress urinary incontinence has not been described.ObjectiveWe sought to study the cross-sectional relationships between urinary microbiota features and demographic and clinical characteristics of women undergoing stress urinary incontinence surgery.Study designPreoperative urine specimens were collected from women without urinary tract infection and were available from 197 women (174 voided, 23 catheterized) enrolled in a multicenter prospective randomized trial, the Value of Urodynamic Evaluation study. Demographic and clinical variables were obtained including stress and urgency urinary incontinence symptoms, menopausal status, and hormone use. The bacterial composition of the urine was qualitatively assessed by sequencing the bacterial 16S ribosomal RNA gene. Phylogenetic relatedness and microbial alpha diversity were compared to demographics and symptoms using generalized estimating equation models.ResultsThe majority of 197 urine samples (86%) had detectable bacterial DNA. Bacterial diversity was significantly associated with higher body mass index (P = .02); increased Medical, Epidemiologic, and Social Aspects of Aging urge index score (P = .04); and hormonal status (P < .001). No associations were detected with stress urinary incontinence symptoms. Increased diversity was also associated with a concomitant lower frequency of Lactobacillus in hormone-negative women.ConclusionWomen undergoing stress urinary incontinence surgery have detectable urinary microbiota. This cross-sectional analysis revealed that increased diversity of the microbiota was associated with urgency urinary incontinence symptoms, hormonal status, and body mass index. In contrast, the female urinary microbiota were not associated with stress urinary incontinence symptoms.
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- 2017
39. Development of a Simplified Patient-Centered Pelvic Floor Surgery Complication Scale
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Fitzgerald, Jocelyn, Richter, Holly E., Sung, Vivian, Dunivan, Gena, Mete, Mihriye, and Gutman, Robert E.
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- 2022
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40. Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse
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Rahn, David D., Richter, Holly E., Sung, Vivian W., Hynan, Linda S., and Pruszynski, Jessica E.
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- 2023
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41. Short-, mid-, and long-term incontinence outcomes in women undergoing mid-urethral sling procedures: a retrospective cohort study
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Malek, Joseph M., Kissane, Lindsay M., Martin, Kimberly D., Meyer, Isuzu, Powell, Thomas Clark, and Richter, Holly E.
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- 2021
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42. Physical performance measures in older women with urinary incontinence: pelvic floor disorder or geriatric syndrome?
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Sanses, Tatiana V. D., Pearson, Sharee, Davis, Derik, Chen, Chi Chiung Grace, Bentzen, Soren, Guralnik, Jack, Richter, Holly E., and Ryan, Alice S.
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- 2021
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43. Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.
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Harvie, Heidi S., Richter, Holly E., Sung, Vivian W., Chermansky, Christopher J., Menefee, Shawn A., Rahn, David D., Amundsen, Cindy L., Arya, Lily A., Huitema, Carolyn, Mazloomdoost, Donna, and Thomas, Sonia
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- 2024
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44. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial
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Weinstein, Milena M., Dunivan, Gena, Guaderrama, Noelani M., and Richter, Holly E.
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- 2022
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45. Incontinence outcomes after “second primary” compared to repeat midurethral sling for recurrent and persistent stress urinary incontinence
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Melnikoff, Anna K., Meyer, Isuzu, Martin, Kimberly D., and Richter, Holly E.
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- 2021
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46. Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial
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Sung, Vivian W, Borello-France, Diane, Dunivan, Gena, Gantz, Marie, Lukacz, Emily S, Moalli, Pamela, Newman, Diane K, Richter, Holly E, Ridgeway, Beri, Smith, Ariana L, Weidner, Alison C, Meikle, Susan, and for the Pelvic Floor Disorders Network
- Subjects
Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Cost Effectiveness Research ,Urologic Diseases ,Comparative Effectiveness Research ,Clinical Trials and Supportive Activities ,Mind and Body ,Clinical Research ,7.1 Individual care needs ,Management of diseases and conditions ,Reproductive health and childbirth ,Renal and urogenital ,Good Health and Well Being ,Female ,Humans ,Patient Selection ,Patient-Centered Care ,Quality of Life ,Research Design ,Surveys and Questionnaires ,Urinary Incontinence ,Mixed urinary incontinence ,Clinical trials ,Sling ,Behavioral therapy ,Pelvic Floor Disorders Network ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine ,Midwifery - Abstract
Introduction and hypothesisMixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.MethodsESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment.ResultsThe final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized.ConclusionsWe describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.
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- 2016
47. Preoperative Urodynamic Parameters (Valsalva Leak Point Pressure and Maximum Urethral Closure Pressure), Urinary Collagen and Plasma Vitamin D Levels as Predictors of Mid Urethral Sling Surgery Outcome
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Chai, Toby C, Moalli, Pamela A, Richter, Holly E, Lake, AeuMuro G, Kim, Hae-Young, Nager, Charles W, Sirls, Larry T, Brubaker, Linda, and Kusek, John W
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Urologic Diseases ,Clinical Research ,Prevention ,Biomarkers ,Body Mass Index ,Collagen ,Female ,Humans ,Middle Aged ,Pressure ,Prognosis ,Risk Factors ,Suburethral Slings ,Urethra ,Urinary Incontinence ,Stress ,Urodynamics ,Urologic Surgical Procedures ,Valsalva Maneuver ,Vitamin D ,urethra ,suburethral sling ,urodynamics ,biomarkers ,outcome assessment ,Clinical Sciences ,Urology & Nephrology ,Clinical sciences - Abstract
PurposeTo determine the best predictor of the mid urethral sling outcome we calculated the AUC of ROC curves of preoperative parameters, including Valsalva leak point pressure, maximum urethral closure pressure, urinary NTx (N-telopeptide of crosslinked type I collagen) and plasma vitamin D values (D2, D3 and D2 plus D3).Materials and methodsThis was an ancillary study of TOMUS (Trial of Mid-urethral Slings) and the ValUE (Value of Urodynamics Evaluation) trial in which subjects underwent mid urethral sling surgery for stress urinary incontinence. Valsalva leak point pressure and maximum urethral closure pressure were measured in 427 subjects, whereas NTx, vitamin D2, vitamin D3 and vitamin D2 plus D3 levels were obtained from 150, 116, 115 and 116 subjects respectively. Outcome success was defined using identical outcome (subjective and objective) variables for all subjects. ROC curves with corresponding AUC values were compared.ResultsTOMUS and ValUE subjects were significantly different in age, body mass index, UDI (Urogenital Distress Inventory) scores. TOMUS subjects had a lower surgical success rate compared to ValUE subjects (66.3% vs 76.0%, p = 0.03). The AUC values of Valsalva leak point pressure, maximum urethral closure pressure, NTx, and vitamins D2, D3 and D2 plus D3 were 0.542, 0.561, 0.702, 0.627, 0.645 and 0.640, respectively. The AUC of NTx was significantly higher than the AUCs of Valsalva leak point pressure and maximum urethral closure pressure (p = 0.02 and 0.03, respectively).ConclusionsUrinary NTx was the best predictor of the mid urethral sling outcome. This test is not only noninvasive, it is also modifiable. Finding ideal modifiable risk factors prior to mid urethral sling surgery should be subject to future investigations.
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- 2016
48. Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse
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Lukacz, Emily S, Warren, Lauren Klein, Richter, Holly E, Brubaker, Linda, Barber, Matthew D, Norton, Peggy, Weidner, Alison C, Nguyen, John N, and Gantz, Marie G
- Subjects
Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Trials and Supportive Activities ,Clinical Research ,Prevention ,6.4 Surgery ,Evaluation of treatments and therapeutic interventions ,Reproductive health and childbirth ,Body Image ,Female ,Humans ,Middle Aged ,Postoperative Period ,Quality of Life ,Sexual Behavior ,Suburethral Slings ,Surveys and Questionnaires ,Urinary Incontinence ,Uterine Prolapse ,Paediatrics and Reproductive Medicine ,Obstetrics & Reproductive Medicine ,Reproductive medicine - Abstract
ObjectiveTo longitudinally assess the effect of native tissue vaginal apical prolapse repair with anti-incontinence surgery on quality of life, sexual function, and body image between uterosacral and sacrospinous suspensions.MethodsA planned secondary analysis was performed on 374 women enrolled in a randomized trial of the two types of native tissue repair for apical prolapse. Condition-specific and generic quality of life, sexual function, overall and de novo dyspareunia, and body image were assessed using validated instruments at baseline; 6, 12, and 24 months postoperatively; and changes from baseline were assessed and compared between surgical groups. General linear mixed models were used for comparisons and clinically significant differences were assessed using minimum important differences.ResultsOf the women randomized, 82% had outcomes available at 2 years. Overall, clinically and statistically significant improvements in generic and condition-specific quality of life and sexual function were observed after surgery. Dyspareunia rates decreased from 25% to 16% by 24 months with only 3% of all women undergoing treatment. De novo dyspareunia occurred in 5% and 10% by 12 and 24 months, respectively. Body image scores also significantly improved from baseline. There were no clinically meaningful or statistically significant differences between groups for any of these outcomes (all P>.05).ConclusionNative tissue vaginal prolapse surgery results in statistically and clinically significant improvements in quality of life, sexual function, and body image at 24 months with no significant differences between uterosacral and sacrospinous suspensions. One in 10 women experience de novo dyspareunia but few requested treatment.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00597935.
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- 2016
49. Pelvic Floor Disorders Registry: Study Design and Outcome Measures.
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Weber LeBrun, Emily, Adam, Rony A, Barber, Matthew D, Boyles, Sarah Hamilton, Iglesia, Cheryl B, Lukacz, Emily S, Moalli, Pamela, Moen, Michael D, Richter, Holly E, Subak, Leslee L, Sung, Vivian W, Visco, Anthony G, Bradley, Catherine S, and American Urogynecologic Society Registry Scientific Committee
- Subjects
American Urogynecologic Society Registry Scientific Committee ,Humans ,Treatment Outcome ,Retreatment ,Registries ,Prospective Studies ,Adolescent ,Adult ,Aged ,Middle Aged ,Female ,Young Adult ,Pelvic Organ Prolapse ,Pelvic Floor Disorders ,Clinical Research ,Contraception/Reproduction ,Patient Safety ,Evaluation of treatments and therapeutic interventions ,6.4 Surgery ,Renal and urogenital ,registry ,urogynecology ,mesh - Abstract
Pelvic floor disorders affect up to 24% of adult women in the United States, and many patients with pelvic organ prolapse (POP) choose to undergo surgical repair to improve their quality of life. While a variety of surgical repair approaches and techniques are utilized, including mesh augmentation, there is limited comparative effectiveness and safety outcome data guiding best practice. In conjunction with device manufacturers, federal regulatory organizations, and professional societies, the American Urogynecologic Society developed the Pelvic Floor Disorders Registry (PFDR) designed to improve the quality of POP surgery by facilitating quality improvement and research on POP treatments. The PFDR will serve as a resource for surgeons interested in benchmarking and outcomes data and as a data repository for Food and Drug Administration-mandated POP surgical device studies. Provider-reported clinical data and patient-reported outcomes will be collected prospectively at baseline and for up to 3 years after treatment. All data elements including measures of success, adverse events, and surgeon characteristics were identified and defined within the context of the anticipated multifunctionality of the registry, and with collaboration from multiple stakeholders. The PFDR will provide a platform to collect high-quality, standardized patient-level data from a variety of nonsurgical (pessary) and surgical treatments of POP and other pelvic floor disorders. Data from this registry may be used to evaluate short- and longer-term treatment outcomes, patient-reported outcomes, and complications, as well as to identify factors associated with treatment success and failure with the overall goal of improving the quality of care for women with these conditions.
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- 2016
50. Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair
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Rahn, David D., primary, Richter, Holly E., additional, Sung, Vivian W., additional, Hynan, Linda S., additional, and Pruszynski, Jessica E., additional
- Published
- 2023
- Full Text
- View/download PDF
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