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BackgroundFecal incontinence affects 7% to 12% of the US adult population, causing social, financial, and quality of life burdens.ObjectiveThe primary aim of this study was to evaluate the efficacy and safety of nonanimal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application.DesignThis was a prospective, single-arm, multicenter, observational Food and Drug Administration-mandated postapproval clinical study.SettingsThis study was designed and executed by participating centers in 18 hospitals and colorectal health clinics in coordination with the Food and Drug Administration and the study sponsor.PatientsA total of 283 subjects who previously failed conservative therapy were enrolled across 18 US sites.InterventionsParticipants received 1 to 2 nonanimal stabilized hyaluronic acid/dextranomer treatments. The first treatment occurred within 30 days of baseline, and a second treatment was administered 1 to 3 months after initial treatment if determined necessary by the physician. Subjects were followed through 7 visits over 36 months after last treatment.Main outcome measuresEfficacy (as specified by the Food and Drug Administration) was measured as a fecal incontinence reintervention rate of

The Pelvic Floor Disorders Consortium (PFDC) is a multidisciplinary organization of colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherap...

INTRODUCTION AND OBJECTIVE:Women with persistent or recurrent SUI following prior surgical intervention have an unmet medical need with symptoms which substantially impact daily functioning and qua...

INTRODUCTION AND OBJECTIVE:This multicenter Phase 3 study (NCT01893138) evaluated efficacy and safety of AMDC-USR compared to PBO for SUI treatment.METHODS:297 adult women with average 14.4 ± 11.4 ...

Objectives The objective of this study was to identify differences in pain perception and satisfaction with pain control in women receiving nonsteroidal anti-inflammatory drugs postoperatively. Methods This was a prospective, randomized controlled trial including urogynecology surgical patients. After surgery, all patients were randomized to receive either intravenous (IV) ketorolac or ibuprofen. The patients completed 3 visual analog scales (VAS) assessing pain at rest, pain with ambulation, and satisfaction with pain control. Postoperative opioid use was also measured. Results A total of 224 patients (112 in each arm) were included. Pain scores (SD) at rest in all patients who received ketorolac versus those who received ibuprofen was 2.30 (2.1) versus 2.68 (2.34) (P = 0.20). Pain scores (SD) with ambulation was 3.94 (2.57) versus 4.16 (2.73) (P = 0.57) in patients who received ketorolac and ibuprofen, respectively. Patients who received ketorolac rated their satisfaction with their pain regimen similarly to those who received ibuprofen (P = 0.50). The average amount (SD) of hydromorphone used in the ketorolac and ibuprofen arm was 3.68 (4.58) mg and 4.04 (4.97) mg, respectively (P = 0.58). A subgroup analysis based on type of surgery showed decreased pain at rest (VAS, 2.77 vs 4.88; P = 0.04) and increased satisfaction (VAS, 1.69 vs 4.67; P = 0.003) in patients who had laparotomy and received ketorolac. Conclusions There was no difference in pain and satisfaction with IV ketorolac compared with IV ibuprofen in patients who underwent all modalities of urogynecologic surgery. A subgroup of patients who underwent laparotomy had less pain with ketorolac.

Objective: To determine whether endovaginal ultrasound is a reliable measure in visualization of the sacrospinous ligament among women with prolapse versus women without prolapse, and thus might be clinically applicable in the design of an ultrasound-guided device for performing sacrospinous ligament anchor placement as a treatment for pelvic organ prolapse. Methods: In the first phase of this study we performed a sacrospinous anchor placement in four normal fresh-frozen female pelves. Afterwards, an endovaginal ultrasound was performed to visualize the anchor localization which was validated by dissection of the cadaveric pelves. In the second phase of the study: two groups of volunteer females with and without pelvic organ prolapsed (POP-group, vs NON-POP group) were evaluated by endovaginal ultrasound to localize the sacrospinous ligament. Results: Cadaveric dissection demonstrated accurate anchor placement into the 8/8 sacrospinous ligament. We performed endovaginal ultrasound in a total of 17 N-POP and 10 (POP) patients. Among the N-POP group, the right and left ischial spines were visible in 6/17 (35%) and (6/17) 35% vs 0/10 (0%) for both right and left sides in POP group (p = 0.008). The right sacrospinous ligament was visualized in 4/17 (23%) N-POP subjects and 0/10 POP subjects (p = 0.27) and the left sacrospinous ligament was visualized in 7/17 (41%) N-POP subjects and 2/10 POP subjects (p = 0.48). Conclusions: Sacrospinous ligament and the ischial spines couldn’t be reliably visualized among women with or without pelvic organ prolapse using endovaginal ultrasound, although the structures are visualized more in some of the non-prolapsed women. The sacrospinous anchoring device demonstrated accurate placement by cadaveric dissections.

The complex levator ani anatomy is perhaps best visualized with three-dimensional endovaginal ultrasonography. In this chapter we will investigate imaging of different levator ani subdivisions and their relationship to the levator plate movement and function. We will also address the occurrence of levator ani muscle injury during childbirth and investigate the role of pelvic ultrasound to identify and quantify the amount of birth-related levator ani muscle trauma.

OBJECTIVE: The goal of this study was to evaluate differences in levator ani hematoma formation within 3 days of delivery between adult women after their first vaginal delivery and adult women who have had multiple vaginal deliveries. METHODS: This was a cross-sectional study at a single institution from 2013 to 2015 using a high-resolution endovaginal ultrasound transducer to identify postvaginal delivery hematoma formation. Logistic regression was used to examine the association between hematoma formation and vaginal parity while considering potential confounders including induction, vaginal operative delivery, vaginal birth after cesarean, fetal weight, fetal head circumference, race and ethnicity, body mass index, age at delivery, gestational age, and length of second-stage labor. RESULTS: Ninety women (46 vaginal-primiparous; 44 vaginal-multiparous) were included in this study. After adjusting for oxytocin use, length of second-stage labor, and body mass index, the odds of pelvic floor hematoma of 1000 mm(3) or greater were 2.93 (95% confidence interval, 0.78–10.91) times greater in women after their first vaginal delivery compared with women with a history of multiple vaginal deliveries. The adjusted odds of pelvic floor hematoma of 1500 mm(3) or greater were 6.02 (95% confidence interval, 1.09–33.24) times greater in vaginal-primiparous compared with vaginal-multiparous women. CONCLUSIONS: Although the prevalence of pelvic floor hematoma was higher in vaginal-primiparous women than vaginal-multiparous women after vaginal delivery, hematomas were present in both groups. Future prospective studies are needed to evaluate the additive effect of multiple vaginal deliveries on the pelvic floor.

Objectives The aim of this study was to determine the prevalence of opioid pain medication use among patients presenting for a new visit to the urogynecology clinic compared with those presenting to general gynecology. Methods We identified all patients who presented for new patient visits to the urogynecology and gynecology clinics between January 1, 2016, and December 31, 2016. Any previous or current opioid use was extracted from the electronic medical record medication list. Statistical analysis was performed using χ and Fisher exact tests for comparisons of categorical variables. Modified Poisson regression models were used to estimate prevalence proportion ratios (PPRs). Results There were 1835 (955 gynecology, 880 urogynecology) patients included. Median age was 47 years (interquartile range, 29 years), and median body mass index was 28.15 kg/m (interquartile range, 9.96 kg/m). Prevalence of opioid use was lowest among women who identified as Asian or other race and highest among black and Native American women; however, when compared by ethnicity, use was lowest among Hispanic women (P = 0.01). Among new urogynecology patients, 14% had self-reported opioid pain medication usage. Opioid use was almost twice as likely in the urogynecology group (PPR, 1.86; 95% confidence interval, 1.4-2.4). When adjusted for confounders, the urogynecology group was 1.3 times as likely to report opioid use (PPR 1.29; 95% confidence interval, 1.0-1.8), with this result approaching statistical significance. Conclusions Opioid use is greater in patients presenting to the urogynecology clinic compared with general gynecology. Urogynecologists need to know this information for planning and optimizing pain management in this population.

OBJECTIVE: The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system. METHODS: This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50% or greater reduction in baseline FI episodes, also assessed at 6 and 12 months. Secondary outcomes included symptom impact measured with Fecal Incontinence Quality of Life scale, symptom severity by the St Mark’s (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events were collected. Primary analysis was intention to treat (ITT). RESULTS: Seventy-three subjects with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6% (53/73, P < 0.0001); per-protocol, 84.1% (53/63, P < 0.0001). Significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark’s questionnaire meeting minimally important differences was noted. Satisfaction was 91.7%, 89.7%, and 94.4% at 3, 6, and 12 months, respectively; 77.4%, 77.6%, and 79.6% were very much/much better on the Patient Global Impression of Improvement at 3, 6, and 12 months, respectively. Most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during fitting period. CONCLUSIONS: In women with successful fitting and initial treatment response, durable efficacy was seen at 3, 6, and 12 months by objective and subjective measures, with favorable safety.

OBJECTIVES To compare digital palpation with levator plate lift measured by endovaginal and transperineal dynamic sonography. METHODS Dynamic transperineal and endovaginal sonographic examinations were performed as part of multicompartmental pelvic floor functional assessment. Patients were instructed to perform Kegel contractions while a probe captured a video clip of levator plate movement at rest and during contraction in a 2-dimensional midsagittal posterior view. We measured the distance between the levator plate and the probe on endovaginal sonography as well as the distance between the levator plate and the gothic arch of the pubis on transperineal sonography. The change in diameter (lift) and levator plate lift ratio (lift/rest × 100) were calculated. Pelvic floor muscle strength was assessed by digital palpation and divided into functional and nonfunctional groups according to the Modified Oxford Scale. Mean differences in levator plate upward lift were compared by Modified Oxford Scale scores using Student t tests and analysis of variance. RESULTS Seventy-four women were available for analysis. The mean age was 55 (SD, 11.9) years. When measured by vaginal dynamic sonography, mean lift and lift/rest ratio values increased with increasing Modified Oxford Scale score (analysis of variance, P= .09 and .04, respectively). When scores were categorized to represent nonfunctional (0-1) and functional (2-5) muscle strength groups, the mean lift (3.2 versus 4.6 mm; P = .03) and lift/rest ratio (13% versus 20%; P = .01) values were significantly higher in women with functional muscle strength. All patients with lift of 30% or greater detected by vaginal sonography had functional muscle strength. CONCLUSIONS A greater levator plate lift ratio detected by dynamic endovaginal sonography was associated with higher muscle strength as determined by the Modified Oxford Scale. This novel measurement can be incorporated into sonographic evaluation of levator ani function.

This study aimed to assess processing of surgical care provided at major Oklahoma City hospitals based on surgeons'perception.A questionnaire was sent out to Oklahoma County Medical Society surgeons using survey monkey to assess surgeons' perception of surgical care provided by major hospitals in Oklahoma City metropolitan area. The email contained a short introduction of study and the general aim of the study. Student t test was applied to compare groups mean. P value0.05 was considered significant.79 valid responses were identified. 25% of surgeons scored that their patients waited in the post-op recovery area between 31-60 minutes before they were roomed, with a 90% surgeon satisfaction rate. Compared to the longer waiting times this satisfaction rate was significantly higher (P0.0001). 64.6% of surgeons reported 31-60 minutes turn-over time between cases with only an 8% satisfaction rate. 10-30 minutes turnover time was reported in 13.9% of participants with 72.7% satisfaction rate which was significant when compared to the former group. The surgeons scored that their patients presented to the hospital 1-2 hours before surgery 55.7% of the times and 92.7% of the surgeons were satisfied with this process (P0.0001).Surgeons'satisfaction increases with decreased patients processing times.

We sought to describe maternal satisfaction with childbirth among women planning either cesarean or vaginal birth. We enrolled primiparous women planning cesarean birth and a comparison group planning vaginal birth. After delivery, the maternal subjective experience was assessed with a visual analogue satisfaction scale and the Salmon questionnaire, with scale scores for these aspects of the maternal experience of birth: fulfillment, distress, and difficulty. The sample included 160 women planning vaginal birth and 44 women planning cesarean. Eight weeks postpartum, women planning cesarean reported higher satisfaction ratings ( P = 0.023), higher scores for fulfillment ( P = 0.017), lower scores for distress ( P = 0.010), and lower scores for difficulty ( P < 0.001). The least favorable scores were associated with unplanned cesarean ( N = 48). Women planning cesarean reported a more favorable birth experience than women planning vaginal birth, due in part to low satisfaction associated with unplanned cesarean. Maternal satisfaction with childbirth may be improved by efforts to reduce unplanned cesarean, but also by support for maternal-choice cesarean.

In certain health care settings, most notably in rehabilitation and palliative care, patients are expected and encouraged to articulate treatment goals and desired outcomes. In obstetrics, patients may voice their preferences via birth plans.1 Birth plans are currently used by women planning both vaginal and cesarean deliveries but have been most often discussed in the context of labor and vaginal delivery. Maternal preferences are important considerations in the management of childbirth, and therefore caregivers should seek information about the values and expectations of obstetric patients. This is particularly important as obstetric providers grapple with an apparent increase in planned cesarean birth.2 Pregnant women strongly prefer a delivery that is safest for their babies and themselves.3 Studies indicate that some women widely perceive cesarean delivery to be as safe as or safer than vaginal birth.4–7 Indeed, some mothers request or agree to cesarean birth because of this belief.4 However, other than an expectation of a safe birth experience, very little is known about what women who request cesarean value regarding the birth experience. In particular, it is not known whether maternal goals for childbirth differ among women who anticipate cesarean versus vaginal birth. We previously described maternal satisfaction with childbirth among women planning either cesarean or vaginal birth.8 In this study, we sought to describe maternal wishes, goals, and expectations for childbirth among women planning cesarean birth compared with a group of women planning vaginal birth. In contrast with other studies exploring women’s reasons for choosing primary cesarean,4–7 our focus was on goals for childbirth among women who had already selected cesarean as a mode of delivery. Our objectives were (1) to develop a framework for describing maternal goals for childbirth, (2) to contrast the goals articulated by women planning vaginal birth with those planning cesarean birth, (3) to investigate goal achievement in both groups, and (4) to investigate the relationship between goal achievement and satisfaction. To our knowledge, there are no current studies comparing maternal goals between planned vaginal and cesarean delivery. Our aim was to investigate whether choice of delivery route would be strongly associated with the type of goals expressed. We also investigated whether goal achievement would be associated with satisfaction with the birth experience in both groups.

We compared the short-term maternal and neonatal outcomes of women who deliver by cesarean without labor compared with women who deliver by cesarean after labor or by vaginal birth. This was a retrospective cohort study of women delivering a first baby from 1998 to 2002. Hospital discharge diagnostic coding identified unlabored cesarean deliveries (UCDs), labored cesarean deliveries (LCDs), and vaginal births (VBs). Medical records were abstracted and mode of delivery confirmed. The three outcomes of interest were maternal bleeding complications, maternal febrile morbidity, and neonatal respiratory complications. Using logistic regression for each outcome, we investigated whether mode of delivery was associated with the outcome, independent of other factors. The study groups included 513 UCDs, 261 LCDs, and 251 VBs. Compared with the UCD group, the adjusted odds of bleeding complications was higher in the LCD comparison group (odds ratio [OR] 2.3; 95% confidence interval [CI] 1.21, 4.53) and the VB comparison group (OR 1.96; 95% CI 0.95, 4.02). The incidence of febrile morbidity was similar for both cesarean groups but lower in the VB group. Both comparison groups had lower odds of neonatal complications than the UCD group (OR for LCD comparison group 0.52; 95% CI 0.27, 0.95 and OR for VB comparison group 0.26; 95% CI 0.098, 0.59). Scheduled cesarean is associated with increased odds of neonatal respiratory complications but decreased odds of maternal bleeding complications.

Objective The objective of this study was to determine the minimum threshold level at which maximum anatomic prolapse predicts bothersome pelvic floor symptoms. Study Design We performed a cross-sectional study of women older than 40 years undergoing gynecologic and urogynecologic examinations using Pelvic Organ Prolapse Quantification (POP-Q) examinations to assess support and Pelvic Floor Distress Inventory questionnaires to assess symptoms. Across the spectrum of prolapse severity, we calculated receiver operating characteristic (ROC) curves and areas under the curves (AUCs) for each symptom. Results Of 296 participants, age was 56.3 ± 11.2 years, and 233 (79%) were white. POP-Q stage was 0 in 39 (13%), 1 in 136 (46%), 2 in 89 (30%), and 3 in 33 (11%). ROC analysis for each symptom revealed an AUC of 0.89 for bulging/protrusion; 0.81 for splinting to void; 0.55-0.62 for other prolapse and urinary symptoms; and 0.48-0.56 for bowel symptoms. Using a threshold of 0.5 cm distal to the hymen, the sensitivity (69%) and specificity (97%) were high for protrusion symptoms but poor for most other symptoms considered. Conclusion Vaginal descensus 0.5 cm distal to the hymen accurately predicts bulging/protrusion symptoms; however, we could not identify a threshold of prolapse severity that predicted other pelvic floor symptoms.

Dear Editor, We are grateful to van der Weiden and Withagen for sharing their findings [1]. We observed an overall de novo SUI rate of almost 30 % among our cohort of open and minimally invasive sacrocolpopexy (SCP) patients with negative preoperative prolapse reduction stress testing (PRST) [2]. In our statistical model, we noted a clear specific relationship between de novo stress urinary incontinence (SUI) and Aa reduction magnitude, regardless of surgical route. Patients with a high (6 cm≥ΔAa 4 cm. Thus, we would agree with cautious and consistent anterior prolapse correction during both PRST and SCP.

score 6 (0–20), and median post-operative clinical POPQ stage 1 (0–2). On ultrasound, clear visualization was obtained in all patients. 8 patients had avulsion defects (75%, 5 bilateral) and all had ballooning on Valsalva. There was no correlation between clinical POPQ staging and ultrasound parameters of prolapse, levator hiatal dimensions or the presence of avulsion defects. Two women were found to have a urethral diverticulum on ultrasound, which was neither symptomatic nor clinically apparent. Conclusions: 4D transperineal ultrasound is an effective tool in the evaluation of vaginal anatomical and functional changes following colpocleisis. It can acquire data that may elude the clinician in view of the obliterative nature of the operation. Future study is warranted to investigate the association between ultrasound findings and patients’ subjective symptoms in a larger cohort.