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OBJECTIVE The aims of this study were to describe the fecal relative abundance of potentially uropathogenic bacteria and to analyze antibiotic resistance genes before and after fecal microbiota transplantation in women with recurrent urinary tract infection (UTI). METHODS Shotgun sequencing was performed on fecal samples from 3 donors and 4 women with recurrent UTI who underwent transplantation. Recipient samples were sequenced at baseline and at 4 time points through 6 months postintervention. Relative fecal uropathogen abundance was analyzed by species and participant using descriptive statistics. Antibiotic resistance gene abundance was assigned, normalized, and compared between donors and recipients at baseline and postintervention using an abundance bar plot, nonmetric multidimensional scaling, and pairwise permutational multivariate analysis of variance. RESULTS The median (range) relative abundance of Escherichia coli in all fecal samples from women with recurrent UTI was 0% (0%-5.10%); Enterococcus faecalis, 0% (0%-0.20%); Enterococcus faecium, 0% (0%-1.90%); Klebsiella pneumoniae, 0% (0%-0.10%); and Pseudomonas aeruginosa, 0% (0%-0.10%). Gut microbes carried genes conferring resistance to antibiotics used for UTI. No significant difference was seen in antibiotic resistance gene carriage after transplantation compared with baseline (P=0.22, R2=0.08 at 3 months). Antibiotic gene composition and abundance were significantly associated with the individual from whom the sample came (P=0.004, R2=0.78 at 3 months). CONCLUSIONS Exploratory analysis of gut microbiomes in women with recurrent UTI identifies no or low relative putative uropathogen abundance for all species examined. Antibiotic resistance gene carriage persisted after fecal microbiota transplantation, although conclusions are limited by small sample size.

Genitourinary syndrome of menopause (GSM) negatively affects more than half of postmenopausal women. Energy-based therapy has been explored as a minimally invasive treatment for GSM; however, its mechanism of action and efficacy is controversial. Here, we report on a pilot imaging study conducted on a small group of menopause patients undergoing laser treatment. Intravaginal optical coherence tomography (OCT) endoscope was used to quantitatively monitor the changes in the vaginal epithelial thickness (VET) during fractional-pixel COsub2/sublaser treatment. Eleven patients with natural menopause and one surgically induced menopause patient were recruited in this clinical study. Following the laser treatment, 6 out of 11 natural menopause patient showed increase in both proximal and distal VET, while two natural menopause patient showed increase in VET in only one side of vaginal tract. Furthermore, the patient group that showed increased VET had thinner baseline VET compared to the patients that showed decrease in VET after laser treatment. These results demonstrate the potential utility of intravaginal OCT endoscope in evaluating the vaginal tissue integrity and tailoring vaginal laser treatment on a per-person basis, with the potential to monitor other treatment procedures.

Author(s): Pezzella, Andrea; McCrery, Rebecca; Lane, Felicia; Benson, Kevin; Taylor, Chris; Padron, Osvaldo; Blok, Bertil; de Wachter, Stefan; Gruenenfelder, Jennifer; Pakzad, Mahreen; Perrouin-Verbe, Marie-Aimee; van Kerrebroeck, Philip; Mangel, Jeffrey; Peters, Kenneth; Kennelly, Michael; Shapiro, Andrew; Lee, Una; Comiter, Craig; Mueller, Margaret; Goldman, Howard B | Abstract: AimsSacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented.MethodsOne hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented.ResultsAt 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their devicenand 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse eventsnoccurred.ConclusionsAt 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements.This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis.The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]).Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

Purpose: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System (TM) is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM(Axonics (R) Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. Materials and Methods: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. Results: At 6 months 90% of participants were therapy responders. The mean +/- SE number of urinary urgency incontinence episodes per day was reduced from 5.6 +/- 0.3 at baseline to 1.3 +/- 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. Conclusions: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Objectives: The aim of this study was to determine if Lysyl Oxidase Like 1 (LOXL1) and Fibulin-5 (Fib5), two crucial proteins in the elastin metabolism pathway, are detectable in the vaginal secretions of women with and without Pelvic Organ Prolapse (POP). We then sought to quantify levels of these proteins in relation to prolapse. Methods: Vaginal secretions were obtained from 48 subjects (13 (27.1%) without and 35 (72.9%) with POP-Q Stage 2-4 prolapse). Eleven (22.9%) subjects were premenopausal and 37 (77.1%) were postmenopausal. Presence of LOXL1 and Fibulin-5 within specimens were first identified via western blotting. Enzyme-Linked Immunosorbent Assays specific for LOXL1 and Fibulin-5 were conducted to quantify total protein secretion. Results: LOXL1 was detected in 45/48 (93.8%) and Fibulin-5 was seen in 24/48 (50%) of subjects. LOXL1 values were lower in women without prolapse (13.3 ng/100 mg median, 24.4 IQR) vs. those with prolapse (26.4 ng/100 mg, 102.2 IQR). On multivariate analysis controlling for age, women with prolapse had a 544% (p=0.0042 higher LOXL1 protein level compared to those without. There was no significant differences in LOXL1 or Fibulin-5 protein detection with relation to menopausal status in bivariate analysis. Conclusions: This is the first published report of non-invasively measuring urogenital LOXL1 and Fibulin-5. In vaginal secretions, LOXL1 protein is higher in subjects with POP than those without.

Background Vulvovaginal involvement in Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) is common, likely underdiagnosed, and can result in severe sequelae if not managed acutely. There are few studies on acute management of vulvovaginal SJS/TEN. Current recommendations are predominantly based on expert opinion. We aimed to determine the frequency of vulvovaginal involvement in SJS/TEN at a single institution, identify treatment modalities, and assess outcomes at a tertiary care burn center. Methods This is a retrospective review of vulvovaginal SJS/TEN cases between 2009 and 2019. Demographic and clinical data including exam findings, treatment regimens, and outpatient follow-up were collected from the electronic medical record. Results Vulvovaginal involvement was observed in 12.7% (19/149) of cases of female patients with SJS/TEN. The mean age was 38.7 years (SD 23.6), and 21% (4/19) of patients were pediatric (age 9-18). Vulvar involvement was seen in 47.3% (9/19), and vulvar plus vaginal involvement was reported in 42.1% (8/19). Treatment regimens were variable until 2017, at which time institutional guidelines were implemented including application of ultrapotent topical steroid, vaginal estrogen, and menstrual suppression. Gynecology follow-up occurred in 15.7% (3/19) of cases. One complication of superficial vaginal agglutination was noted and was successfully treated in the office with blunt dissection. Conclusion The most common treatment modalities employed at our institution included application of ultrapotent topical steroid, vaginal estrogen, and menstrual suppression. While follow-up was limited for our patient population, we propose an algorithm to prevent long-term sequalae of vulvovaginal SJS/TEN. Gynecologic surveillance is recommended to reduce urogynecologic sequelae.

OBJECTIVES This study aims to determine the effect of opioid-specific counseling on postdischarge opioid consumption and opioid storage/disposal patterns after reconstructive pelvic surgery. METHODS In this multicenter randomized-controlled trial, participants were randomized to standard generalized counseling or opioid-specific perioperative counseling. Opioid-specific counseling was provided at the preoperative and 2-week postoperative visits with educational handouts about the risks of opioids and U.S. Food and Drug Administration recommendations for appropriate opioid storage and disposal. The primary outcome was morphine milligram equivalent (MME) consumption between hospital discharge and 2 weeks postoperatively. Secondary outcomes included opioid storage 2 weeks postoperatively, opioid disposal 6 weeks postoperatively, and rate of opioid refills. RESULTS Among 70 opioid-specific and 65 standard counseling participants, there were no significant differences in demographic characteristics, type of surgery, concomitant hysterectomy, or perioperative complications. For the primary outcome, there was no significant difference in median opioid consumption between the 2 arms. Median (interquartile range) postdischarge MME consumption for all participants was 15 mg (0-75). Forty percent of participants denied postdischarge MME consumption. For secondary outcomes, there were no significant differences in appropriate opioid storage between groups. The appropriate disposal rate of unused opioid tablets 6 weeks after surgery was higher among participants who received opioid-specific counseling. The rate of opioid refill was 7.4%. CONCLUSIONS Opioid-specific counseling did not affect postdischarge consumption but increased the disposal rate of unused opioid tablets 6 weeks postoperatively. Opioid-specific counseling could minimize the potential for opioid misuse by reducing the number of unused opioid tablets in patients' possession after surgery.

Fecal microbiota transplantation may reduce urinary tract infection by altering gut microbiome.

Author(s): Benson, Kevin; McCrery, Rebecca; Taylor, Chris; Padron, Osvaldo; Blok, Bertil; de Wachter, Stefan; Pezzella, Andrea; Gruenenfelder, Jennifer; Pakzad, Mahreen; Perrouin-Verbe, Marie-Aimee; Van Kerrebroeck, Philip; Mangel, Jeffrey; Peters, Kenneth; Kennelly, Michael; Shapiro, Andrew; Lee, Una; Comiter, Craig; Mueller, Margaret; Goldman, Howard; Lane, Felicia | Abstract: AimsSacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented.MethodsA total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants.ResultsAt 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events.ConclusionsThe Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

INTRODUCTION AND OBJECTIVE:Sacral neuromodulation (SNM) is a guideline-recommended treatment for certain types of urinary dysfunction and fecal incontinence. The Axonics System is a miniaturized, r...

Despite the emerging market in energy-based devices to treat Genitourinary Syndrome of Menopause (GSM) in menopausal women, the exact effect of the laser on vaginal tissue remains poorly understood. We developed a point-of-care intravaginal endoscope that can obtain simultaneous information on structural and vascular information during the vaginal laser procedure. We evaluated the capability of assessing the treatment outcome by investigating patients receiving the CO2 fractional laser treatment. Our study supports the hypothesis that the treatment effect highly depends on the initial tissue parameters such as epithelium thickness and vascular density.

OBJECTIVE: Optical coherence tomography is a noninvasive technology that visualizes tissue microstructure with high spatial resolution. We designed a novel vaginal system that demonstrates a clear distinction between vaginal tissues planes. In this study, we sought to compare vaginal tomographic images of premenopausal, perimenopausal, and postmenopausal women, demonstrate feasibility of tracking vaginal tissue changes after treatment with fractional-pixel CO(2) laser therapy, and obtain a histologic correlation of these findings. METHODS: Enrolled subjects underwent imaging and were divided into 3 groups based on menopausal status. Women with genitourinary syndrome of menopause who received fractional-pixel CO(2) laser therapy were assessed before and after treatment. A cadaveric vagina was used to obtain tomographic and histologic images to assess for accuracy. Our primary outcome was mean vaginal epithelial thickness. Statistical analysis was performed using analysis of variance and t tests, respectively. RESULTS: Among 6 women, the mean vaginal epithelial thickness decreased with menopause (P < 0.01). Although change in epithelial thickness after fractional-pixel CO(2) laser treatment varied between the 2 subjects evaluated, it increased significantly for the subject who reported improvement of vaginal symptoms (P < 0.01). Using a cadaveric specimen, optical biopsy was correlated to an hematoxylin and eosin–stained biopsy of the same vaginal site. CONCLUSIONS: This study establishes feasibility of optical coherence tomography in providing an optical biopsy of the vaginal epithelium and lamina propria. In addition, it demonstrates vaginal changes as women enter menopause. This report is the initial phase of a longitudinal cohort study to evaluate changes in vaginal microstructure after energy-based treatment.

Objectives Optical coherence tomography (OCT) can noninvasively visualize in vivo tissue microstructure with high spatial resolution that approaches the histologic level. Currently, OCT studies in gynecology are few and limited to a conventional 1.3 μm center wavelength swept light source which provides high spatial resolution but limited penetration depth. Here, we present a novel endoscopic OCT system with improved penetration depth and high resolution. Methods A novel endoscopic OCT system was developed based on a 1.7 µm swept source laser, which is capable of deeper tissue penetration due to its longer wavelength. To evaluate the performance of system, we imaged the human vaginas in vivo with both conventional 1.3 and 1.7 μm endoscopic OCT systems. Results With the 1.7 μm endoscopic OCT system, imaging depth was improved by more than 25%, allowing better visualization of the lamina propria and clear contrast of the epithelial layer from the surrounding tissues. Conclusion The significantly improved performance of the novel 1.7 μm OCT imaging system demonstrates its potential use as a minimally-invasive monitoring tool of vaginal health in gynecologic practice. Lasers Surg. Med. 51:120-126, 2019. © 2018 Wiley Periodicals, Inc.

The pubovaginal sling (PVS) dates to the 1940s as an efficacious surgical treatment for stress urinary incontinence (SUI). Recently, it has been replaced by the midurethral sling (MUS). Since 2008, international regulatory agencies increased regulation and issued warnings on vaginal mesh for repair of pelvic organ prolapse (POP), which has led to increased scrutiny of the MUS. Thus, the need for surgical comfort with PVS is resurfacing. We sought to evaluate the surgical practice patterns among international urogynecologists for the treatment of SUI and identify whether a need and interest for more training exists. We developed a short, Internet-based survey for members of the International Urogynecological Association (IUGA). Descriptive analyses, binomial and multivariate logistic regressions were calculated to determine significant associations. Among 556 members who responded to the survey, 72% did not offer PVS in practice. Among those who did, there was as significant relationship between offering PVS and practicing in the United States, board-certification in urogynecology, PVS exposure in training, increasing number of PVS performed during training, and comfort with PVS. Members interested in further PVS training were younger, less comfortable with PVS, performed fewer PVS, or had no exposure in training. Most IUGA members do not offer PVS in clinical practice. As would be expected, members who performed more PVS in training and were more comfortable with PVS were likely to offer it to patients. Our results highlight a learning gap, especially among younger providers who are not comfortable with PVS and desire further training in this procedure.

Sacral neuromodulation and intradetrusor onabotulinum toxinA are FDA approved treatment options for overactive bladder (OAB) and considered third-line therapies according to the American Urological Association (AUA) guidelines. Although each therapy has unique associated risks, infection is a common adverse event shared by both. The purpose of this review is to identify risk factors for infection in third-line therapies for OAB. A PUBMED® and MEDLINE® search was performed for scientific publications on “sacral neuromodulation,” “sacral nerve stimulation,” “onabotulinum toxinA,” “Botox,” “percutaneous tibial nerve stimulation (PTNS)” and “infection,” and “overactive bladder (OAB)” between the years 2003 and 2016. Articles were screened for reports on adverse events and were included in the review if they contained information on infection. We also limited this review to idiopathic OAB in adults. A total of 127 articles were identified (61 in the onabotulinum toxinA and 64 in the sacral neuromodulation (SNM) groups, respectively, and two containing combined data). No articles referencing PTNS and infection were identified; thus, PTNS is not reviewed in this manuscript. Twenty-nine articles met criteria and served as the source information for this article. The primary infection associated with sacral neuromodulation is device-related and ranges between 1.7 and 7.8% in patients implanted for OAB. The most common infection in the onabotulinum toxinA group is a urinary tract infection, with rates ranging from 9.5 to 44%, with the vast majority classified as uncomplicated. Potential risk factors for surgical site infection associated with SNM include patients who are immunocompromised, those with diabetes, or those with a higher BMI. Potential risk factors for urinary tract infection (UTI) associated with onabotulinum toxinA include active medication vs. placebo, urinary retention, and the use of clean intermittent catheterization. Onabotulinum toxinA and SNM are safe and effective third-line therapies for refractory OAB. Onabotulinum toxinA injection is associated with UTIs, and risk factors appear to be the use of active drug vs. placebo, urinary retention, and use of clean intermittent catheterization. In contrast, SNM is associated primarily with surgical site infection. Risk factors identified include diabetes, higher BMI, or immunocompromised status.

Background Postpartum hemorrhage is the most common cause of maternal morbidity in the United States. However, secondary postpartum hemorrhage is rare and includes pseudoaneurysms, which represent only 3.3% of all cases of secondary postpartum hemorrhage. Vulvar labial artery pseudoaneurysm had never been reported in the literature. Case This is a case of ruptured vulvar labial pseudoaneurysm leading to secondary postpartum hemorrhage. Computerized tomography angiography showed it to be located in a distal branch of the vulvar labial artery. This location is unique, although there are reported cases of pseudoaneurysms in the uterine artery. The patient was successfully treated with arterial embolization. Conclusion Recognition of a ruptured pseudoaneurysm as the cause of postpartum hemorrhage allows for its proper management by arterial embolization., Highlights • Ruptured pseudoaneurysms have mostly been described in the uterine arteries. • Pseudoaneurysms rarely occur in distal branches of the internal pudendal artery. • Vulvar labial pseudoaneurysm has yet to be described in the literature. • Computerized tomography angiography is the preferred study for the diagnosis of a pseudoaneurysm. • Embolization by interventional radiology is the treatment of choice for a ruptured pseudoaneurysm.

OBJECTIVES The aims of the study were to identify patient-centered applications (apps) in female pelvic medicine and reconstructive surgery and to evaluate them using a modified APPLICATIONS scoring system. METHODS A comprehensive list of female pelvic medicine and reconstructive surgery search terms was used to identify apps in the iTunes store. Apps that were eligible for scoring were in English, pertinent to the search term, patient centered, and accurate. All five authors independently evaluated eligible apps using a modified APPLICATIONS scoring system and subsequently reconciled differences by discussion. RESULTS One hundred and fifty-seven terms were generated and searched in the iTunes Store to reveal 4127 apps. Twenty-three eligible apps were scored. Approximately half (47%, 11/23) of the apps were free. Twelve (52%) apps cited scientific literature or expert source. Only 8 (35%) of the apps were also available in the Google Play Store. "Squeezy," "LeakFreeMe," and "Stop UTI" received the highest score of 14. CONCLUSIONS Few identified apps were accurate and subsequently scored. Our results demonstrate that when searching for apps, patients are likely to obtain information that is not relevant or inaccurate, even if the appropriate search term is used. By carefully excluding inaccurate apps, providers should feel confident that the 23 scored apps can be shared with patients.

OBJECTIVES To assess for stem cell migration to liver and lung after transplantation in injured rat anal sphincters. To evaluate histological findings of unanticipated ectopic foci of growth. METHODS This is a prospective study involving 33 female virginal Sprague-Dawley rats. Anal sphincters were transected and repaired under sterile technique. Animals received injections of 5.0 × 10 myogenic stem cells (24 rats) or sham control (9 rats) and were killed on day 30. Liver and lung samples were obtained. Upon encountering abnormal foci of growth, further staining protocols were employed. Enzyme-linked immunosorbent assay studies evaluated stem cell media for in vitro growth factor secretion. RESULTS No evidence of cell migration to liver or lung was found at the time of euthanasia in any study animal. Ectopic foci of growth were noted in 2 transplant rats. Further histological evaluations of these growths were consistent with benign tumors: no nuclear abnormalities and no evidence of proliferation at day 30. Enzyme-linked immunosorbent assay studies demonstrated positive secretion of vascular endothelial growth factor and insulin growth factor into the media of cultured rat myogenic stem cells. CONCLUSIONS Whereas distant migration was not encountered in the liver or lung, 2 transplanted rats developed abnormal foci of growth, that is, tumors, from the external anal sphincter-raising further safety questions. Additional evaluation of these foci seemed benign. Possible explanations include cell trapping, stem cell overgrowth, and/or paracrine factors. The lack of cell migration supports that future investigation of safety parameters could focus locally.

Aims To assess whether InterStim lead wire placement with the curved stylet achieves motor response at lower amplitudes compared to straight stylet use. Methods This was a prospective, randomized, crossover study of patients scheduled for InterStim lead wire placement. All patients underwent lead wire testing with both the curved and straight stylets. Patients were randomized to determine stylet order, and then crossed-over to the alternate. Intra-operatively, the amplitude achieving motor response at each electrode was recorded. The stylet with lowest overall amplitudes was used for final placement. Primary outcome measure was amplitude requirement in the two deepest (0 and 1) electrodes. Secondary outcomes included amplitudes at the number 2 and 3 electrodes, combined amplitudes, stylet order, and adverse outcomes. Results Forty-two patients were enrolled, 40 of whom were included in the final analysis. Mean age was 69 years (SD = 12.8) and mean BMI 27 (SD = 5.6). Indications for placement included: urge urinary incontinence (N = 26), urge/frequency (N = 25), non-obstructive urinary retention (N = 5), and fecal incontinence (N = 10). There were no significant differences between randomized groups. Regardless of order, the curved stylet achieved a motor response at lower amplitudes in the deepest electrodes (P

OBJECTIVE : The ideal graft material for pelvic reconstructive surgery remains undetermined. The purpose of this study was to present data on novel composite biologic/synthetic grafts during use in abdominal sacrocolpopexy. METHODS : A case series of 90 patients undergoing abdominal sacrocolpopexy with composite biologic/synthetic grafts was conducted. The primary outcome was graft erosion. Assuming a 3% risk of reoperation for mesh erosion, the number needed to treat with a composite graft in order to avoid erosion risk from a synthetic-only graft was calculated. The cost of a composite graft was compared to reoperation costs for mesh erosion of a synthetic-only graft. RESULTS : Zero patients (N = 90) undergoing abdominal sacrocolpopexy with a composite biologic/synthetic graft experienced graft erosion. Based on existing data, thirty-three patients would need to be treated with a composite graft to avoid one mesh erosion from a synthetic-only graft. If a $500 composite graft is used, the cost of reoperation performed abdominally is higher. CONCLUSIONS : This study introduces a novel biologic/synthetic composite graft that offers the advantage of low erosion risk during use in abdominal sacrocolpopexy. Combined grafts may also be cost-effective. Future research should focus on exploring the role of these durable, yet low erosion risk grafts to potentially promote improved safety for our patients and cost savings for society.

OBJECTIVES : To determine the feasibility of injecting rat myoblasts into the intact anal sphincter as a potential treatment for anal incontinence, and to detect transferred myoblast survival and integration. STUDY DESIGN : A pilot study using nonpregnant female Sprague Dawley rodents of 8 to 10 weeks of age. A biopsy of skeletal muscle was harvested from a study animal and recovered myoblasts were expanded in vitro over 10 days. Myoblasts were then tagged with a cytomegalovirus promoter to transduce green fluorescent protein (GFP) into the myoblasts. The cell aspirate was injected directly into the intact external anal sphincter using an electromyographic guidance. The animals received 1.5 or 4.5 × 10 cells of GFP-labeled myoblasts, dividing the dose between three injection sites. The remaining in vitro myoblasts were still viable 28 days post-harvest. Ten days after transplantation the anal sphincter complex was surgically extracted. RESULTS : The presence of GFP-labeled myoblasts was confirmed within the external anal sphincter. CONCLUSIONS : This demonstrates that myoblasts can be successfully extracted, cultivated in vitro, transplanted and will integrate into the host tissue.

The objective of this study is to determine the outcomes for the Lynx® midurethral sling system in the treatment of urodynamic stress incontinence (USI). Prospective study of 118 subjects who underwent a Lynx® midurethral sling procedure for USI. Subjects were considered cured if they were subjectively dry by history and objectively dry by standing stress test. Intraoperative and postoperative complications were documented. Complete information was available on 102 (86%) subjects at 1 year. Ninety-two patients were considered cured, and ten were failures. There were four intraoperative bladder perforations and five (4.2%) erosions. Two patients developed urinary retention with one resolving at 31 days and the other undergoing subsequent takedown at 6 months. Both remain dry at 12 months. The Lynx® midurethral sling system shows high subjective and objective success rates for the treatment of USI at 1 year with low rates of intraoperative and postoperative complications.

Objective The Accreditation Council for Graduate Medical Education measures surgical residents’ experience in the United States by mandating that residents log each procedure in which they have participated. This system is the primary mechanism by which breadth and depth of surgical training are documented, and data are used for program accreditation and by individual program directors to assess resident preparedness. The study objective was to learn from residents across surgical specialties how this system is being used, and whether they believe these data are reliable. Design Investigators developed and administered a voluntary, 45-item survey. Resident demographic data, program details, logging behaviors, and attitudes were examined using descriptive statistics. Authors used multivariate logistic regression to assess respondent and program characteristics associated with logging habits. Setting The survey was administered at a large academic medical center. Participants All general surgery, obstetrics and gynecology, orthopedics, urology, neurosurgery, otolaryngology, and plastic surgery residents were eligible. Of 126 surgical residents, 82 participated, yielding a response rate of 65%. Results Overall, 7.5% considered the case log system highly inaccurate, 28.8% somewhat inaccurate, 52.5% somewhat accurate, and 11.3% highly accurate. Nearly half (48.1%) use an incorrect metric to log their role as surgeon or assistant. Half logged monthly or less frequently. The longest time residents reported falling behind ranged from less than a week to more than a year, with about half (51.4%) reporting backlogs of 3 months or longer. Approximately two-thirds considered the system difficult to navigate (64.2%) and burdensome (68.8%). Departmental training and reminders to log were associated with high fidelity logging habits. Conclusions Inconsistency of logging habits and perceived lack of accuracy raise concerns about use of the system for assessing surgical preparedness or accrediting training programs. Academic departments playing an active role may benefit from more reliable data to guide improvements in surgical training.

Objective: To determine if women with anterior support stages 0 or I by pelvic organ prolapse quantification (POP-Q) system require Q-tip testing to assess urethral mobility. Methods: A prospective study of 134 women presenting for urogynecologic evaluation were examined and assigned stages of anterior wall support according to the POP-Q system. A Q-tip test was performed and urethral hypermobility was defined as a straining angle ≥30°. The Spearman correlation coefficient was used to assess degree of correlation between POP-Q point Aa position and Q-tip values. Results: The correlation coefficient between point Aa position and Q-tip angle was r=0.787 (P

Objectives : The objectives of this study were to determine the number of patients implanted with sacral neuromodulation (SNM) for overactive bladder (OAB) who required supplemental or continued anticholinergic (ACH) therapy for improved response and to identify factors predictive of requiring supplemental ACH. Materials and methods : This is a retrospective chart review of 148 patients who underwent SNM from 1999 to 2007. Patients included were those implanted for urgency, frequency, or urge incontinence. Eighty-eight patients were included in the analysis. A stepwise regression analysis was performed to identify factors predictive for restarting ACH medication. Results : All patients underwent SNM implantation for frequency-urgency and urge incontinence. Of all patients, 16 (18%) required supplemental ACH therapy for improved symptom control. Overall, 26 patients (25%) either continued or were started on ACH therapy in addition to SNM for improved outcomes. Conclusions : A subset of patients had improved therapeutic response with combined SNM and ACH therapy. The only factor associated with supplemental ACH use was body mass index.

INTRODUCTION This is an observational study is designed to assess the influence of age, prolapse and medical co-morbidities on myogenic stem cells growth in-vitro. METHODS A biopsy of the rectus abdominus muscle was obtained during surgery in patients with and without pelvic organ prolapse (POP). Nuclei number and fiber count were correlated with patient's age, presence of POP, and medical comorbidities. Efficiency of expansion of myogenic stem cells in vitro was calculated. The percentage of Pax7-, MyoD-, and desmin-positive cells was correlated with age, POP status, and medical comorbidities. RESULTS A total of 17 specimens were obtained; 13 specimens were available for histologic analysis. There was no correlation between patient's age, POP status or medical comorbidities and nuclei or fiber count, growth rate, or the percentage of Pax7- and MyoD-positive cells. Patients with 2 to 4 medical comorbidities were noted to have a significantly lower percentage of desmin-positive cells. Specimens with a higher nuclear count had significantly better cellular expansion. Data were analyzed using Kruskal-Wallis or Wilcoxon rank sum statistics. CONCLUSIONS Multiple medical comorbidities but not patient's age or POP status influenced in vitro myogenic stem cell growth. These data suggest that patients with advancing age or POP may be acceptable autologous donors if treatment of urinary or anal incontinence requires myoblast transplantation.

OBJECTIVE This study aims to evaluate in vivo function of the external anal sphincter after transection and repair augmented with myogenic stem cells, and to establish normative electromyography parameters of the rodent external anal sphincter. DESIGN AND SETTING Thirty-three Sprague-Dawley rodents underwent baseline needle electromyography of the external anal sphincter. Motor unit action potentials were obtained and normative parameters established. Animals were randomly assigned to a myogenic stem cell group (n = 24) or control group (n = 9). All underwent proctoepisiotomy. The control group underwent layered repair with phosphate-buffered saline injection to the external anal sphincter. The treatment group underwent identical repair with injection of myogenic stem cells 5.0 × 10. Baseline anal pressure recordings were collected and repeated 2 weeks postintervention, and electromyography was repeated at 2 and 4 weeks. Groups were compared across 3 time points with the use of repeated measures ANOVA. MAIN OUTCOME MEASURES The primary outcomes measured were the functional recovery of rat anal sphincters after stem cell transplantation as assessed by objective electromyography and anal pressure measures. RESULTS A mean of 17 motor unit action potentials were sampled per animal. At 2 weeks postrepair, there was a significant difference between control and transplant groups with respect to amplitude, duration, turns, and phases (p < 0.01 for each). No significant electromyography differences were seen at 4 weeks. Resting and peak anal pressures declined significantly at 2 weeks postinjury in the control but not in the stem cell group. LIMITATIONS Use of a murine animal population limited the subjective feedback and wider applicability. CONCLUSIONS In vivo functional studies show recovery of anal sphincter pressures and electromyography to preinjury levels by day 14 in the myogenic stem cell group but not controls. At 4 weeks, all electromyography parameters returned to baseline irrespective of group. Restoration of function may be accelerated by the transplantation of myogenic stem cells and associated trophic factors.

Stem cell based therapies hold promise for the obstetrician and gynecologist. This article reviews the history of stem cells and some of their current applications in gynecology. Currently, mesenchymal and muscle-derived stem cells are being explored for the treatment of urinary and anal incontinence. Potential stem cell treatments include fistula repair, vaginal tissue engineering, and graft material enhancement. Published animal and human pilot studies demonstrate improved histologic and functional outcomes in those receiving stem cells. Transplanted cells may improve function by local engraftment, trophic factors, or modulation of inflammation. Further clinical and safety studies are needed before clinical application.