Case log trends of urogynecology and reconstructive pelvic surgery fellows: A comparison of urology- and gynecology-based fellowship programs.

AIMS: Urogynecology and Reconstructive Pelvic Surgery (URPS) fellowship can be pursued after completion of either a urology (URO) or obstetrics and gynecology (GYN) residency. Our aim is to determine differences in graduating fellow cohort (GFC) case logs between URO- and GYN-based URPS programs. METHODS: Accreditation Council for Graduate Medical Education case logs for URPS GFCs in both GYN- and URO-based programs were analyzed for the 2019-2023 academic years (AY). Unpaired t-tests with Welch's correction were used to compare annual mean logged cases between URO- versus GYN-based GFCs for select surgical categories and the top 11 most logged index cases. RESULTS: GYN-based GFCs logged more cases for all pelvic organ prolapse (POP) categories including surgery on apical POP, anterior wall POP, and posterior wall POP (all p < 0.01), while URO-based GFCs logged more cases for surgery on the urinary system (p = 0.03). For the top 11 logged procedures, URO-based GFCs logged more sacral neuromodulation cases (p = 0.02), whereas GYN-based GFCs logged more slings, vaginal hysterectomies, minimally-invasive hysterectomies, vaginal apical POP, vaginal posterior POP, vaginal anterior POP, and minimally-invasive apical POP cases (all p < 0.01). There was no difference between URO- and GYN-based GFCs for complex urodynamics, cystoscopy with botox injection, or periurethral injection cases. CONCLUSIONS: URO-based URPS fellows tend to graduate with more surgery on the urinary system and sacral neuromodulation cases, while GYN-based fellows perform more slings, hysterectomies, and POP surgery. These findings may help fellowships better understand potential differences in training among graduates from URO- and GYN-based programs and encourage collaboration to lessen these discrepancies.

Postoperative Activity Restrictions After Slings: A Randomized Controlled Trial.

IMPORTANCE: Restricting activity after midurethral slings is an unproven practice. OBJECTIVE: The objective of this study was to evaluate the effect of postoperative activity restriction on satisfaction and outcomes after slings. STUDY DESIGN: This was a multicenter, 2-arm, noninferiority randomized controlled trial. Patients aged 18-85 years undergoing treatment with a midurethral sling were randomized 1:1 to postoperative activity restriction or liberal activity. Restrictions included avoidance of strenuous exercise and heavy lifting. The liberal group was allowed to resume activity at their discretion. Our primary outcome was satisfaction with postoperative instruction at 2 weeks. Secondary outcomes included surgical failure, mesh exposure rates, and other adverse events. RESULTS: In total, 158 patients were randomized with 80 to the liberal group and 78 to the restricted group. At 2 weeks, 54 (80.6%) of patients in the liberal group and 48 (73.9%) of patients in the restricted group were satisfied. We found statistical evidence supporting the hypothesis that postoperative liberal activity instruction is noninferior to activity restriction with regard to patient satisfaction (P = 0.0281). There was no significant difference in strenuous activity at 2 weeks (P = 0.0824). The liberal group reported significantly more moderate activity at 2 weeks (P = 0.0384) and more strenuous activity at 6 weeks and 6 months (P = 0.0171, P = 0.0118, respectively). The rate of recurrent or persistent stress incontinence for liberal versus restricted groups was 18.52% versus 23.53% (P = 0.635). There were no statistically significant differences in complication rates. CONCLUSIONS: Postoperative liberal activity was noninferior to activity restriction with regard to patients' satisfaction. There was no evidence supporting a statistically significant association between postoperative instruction and negative surgical outcomes.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair.

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. STUDY DESIGN: A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was 280. RESULTS: Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval, -0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. CONCLUSION: For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Vaginal Estrogen Prescribing and Cost Trends Among Medicare Part D Beneficiaries.

IMPORTANCE: In 2016, the American College of Obstetricians and Gynecologists issued a Committee Opinion on the safety of vaginal estrogen (VE) in estrogen-dependent breast cancer patients. Since that time, prescribing trends of VE have not been studied. OBJECTIVE: Our objective was to analyze expenditure and prescribing trends of VE from 2016 to 2020 for Medicare Part D beneficiaries. STUDY DESIGN: In this retrospective review, we queried the Medicare Part D Spending and Prescriber Datasets from 2016 to 2020 to identify claims for VE. Trends regarding claims, expenditures, beneficiaries, and prescribers were examined. A subanalysis of the Medicare Part D Prescriber Dataset was performed for obstetrician-gynecologist-specific trends. Statistical analysis was done with the Kruskal-Wallis test. RESULTS: From 2016 to 2020 for all specialties, the number of VE claims decreased annually from 945,331 in 2016 to 320,571 in 2020. Most claims were for Estrace (49.5%) followed by Yuvafem (23.3%), Vagifem (14.5%), and Estring (12.7%). The number of VE prescribers decreased from 20,216 to 5,380, with obstetrician-gynecologists comprising 60% of all prescribers. Beneficiaries decreased by more than 70% from 439,210 to 123,318, whereas average spending per beneficiary increased from $688.52 to $1,027.55. Total annual spending on VE decreased from $277,891,645 to $106,679,580. However, average spending per claim increased from $293.40 to $355.28 and increased for all products besides Yuvafem. CONCLUSIONS: Vaginal estrogen claims, beneficiaries, and total expenditures across all provider types have decreased from 2016 to 2020. However, spending per beneficiary and VE claims have increased. Our data suggest that utilization and accessibility of vaginal estrogen may be influenced, in part, by cost.

Third-Line Overactive Bladder Therapies on TikTok: What Does the Public Learn?

IMPORTANCE: Millions of people rely on social media platforms, including TikTok, for health-related information. TikTok has not yet been evaluated as an information source for overactive bladder (OAB) third-line therapies. OBJECTIVES: Our aim was to assess TikTok videos on third-line therapies for OAB for misinformation and quality. STUDY DESIGN: In this cross-sectional analysis, we abstracted the top 50 TikTok videos for keywords: "Axonics," "sacral neuromodulation," "Interstim," "PTNS," "posterior tibial nerve stimulation," and "bladder Botox." Videos were scored for quality by 3 independent reviewers using the Medical Quality Video Evaluation Tool (MQ-VET). Two reviewers determined if videos contained misinformation. RESULTS: Of 300 videos screened, 119 videos were included. Twenty-four (21%) were created by medical professionals (MPs). Medical professional videos were more frequently shared (5 vs 1, P < 0.01) but had similar views, likes, comments, and length. Although MP videos had significantly higher MQ-VET scores (43 vs 27, P < 0.01), there was no difference in the rate of misinformation between MP and non-MP videos (21% vs 18%). Twenty-two videos (18.4%) contained misinformation, which were 3 times longer (50.5 vs 15 seconds, P < 0.01) and had higher MQ-VET scores (34.5 vs 27, P = 0.03) than those without misinformation. Common themes of misinformation pertained to therapy indication, mechanism of action, and patient limitations after undergoing therapy. CONCLUSIONS: Many TikTok videos on OAB third-line therapies contain misinformation. Most of these videos were not of high quality and created by the public. Medical professionals should be aware of misinformation permeating TikTok, given its large audience, and aim to promote or offer educational material of better accuracy and quality.

Assessment of Level of Fear in Adult Patients Undergoing Elective Urogynecologic and Gynecologic Procedures and Surgeries During the COVID-19 Pandemic Using the Validated Surgical Fear Questionnaire.

OBJECTIVE: This study aimed to assess and trend fears surrounding elective surgery and office procedures in benign gynecologic and urogynecologic patients during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: This was a multicenter, prospective, observational study. Recruitment occurred from June 23, 2020, to March 23, 2021. Females 18 years or older presenting for elective benign gynecologic or urogynecologic surgery or office procedures were eligible. Patients were excluded if non-English speaking or undergoing an emergent procedure or surgery. Fear was assessed by the Surgical Fear Questionnaire (SFQ), which was also modified to include 2-4 additional questions pertaining to COVID-19 (modified version of the Surgical Fear Questionnaire [mSFQ]). Total SFQ scores and short- and long-term fear scores were compared between procedures and surgery and to historic data. RESULTS: A total of 209 patients undergoing 107 procedures or 102 surgical procedures completed the questionnaire. Participants were separated into subgroups determined by the timing of questionnaire completion related to phases of the pandemic. The most common procedure was urodynamics (n = 59 [55%]). The most common elective surgical procedure was hysterectomy (n = 59 [57.8%]). Furthermore, 72.5% of surgical procedures were for urogynecologic indications.Fear levels were low and not different in patients undergoing procedures versus surgery (12.38 ± 12.44 vs 12.03 ± 16.01, P = 0.958). There was no difference between procedures versus surgery for short- (6.21 ± 8.38 vs 6.81 ± 8.44, P = 0.726) or long-term fear (6.18 ± 8.89 vs 5.22 ± 8.20, P = 0.683). Compared with historic data, our hysterectomy patients had less surgical fear. The mSFQ demonstrated higher fear scores for both procedures and surgery (mSFQ, 20.57 ± 20.55 for procedures; 28.78 ± 28.51 for surgery). There were no significant fluctuations in SFQ score in relation to critical COVID-19 events. CONCLUSIONS: Fear of surgery and office procedures was low and consistent throughout the COVID-19 pandemic and lower than historic data.

Evaluation of the histological and biomechanical properties of poly-4-hydroxybutyrate scaffold for pelvic organ prolapse, compared with polypropylene mesh in a rabbit model.

INTRODUCTION AND HYPOTHESIS: Poly-4-hydroxybutyrate (P4HB) is a biopolymer produced by Escherichia coli K12 bacteria. P4HB is fully resorbed in vivo by 18-24 months post-implantation. The aim of this study is to evaluate P4HB in the rabbit abdomen and vagina to determine that the biomechanical and histological properties are similar to the standard polypropylene mesh. Our hypothesis is that the histological and biomechanical properties of a fully absorbable graft will be similar to a lightweight polypropylene (PP) mesh when implanted in rabbit vagina and abdomen. METHODS: Sixteen (n = 16) female New Zealand White (retired breeder) rabbits were equally divided between two time points (3 and 9 months). A total of 17 rabbits were used owing to one death secondary to suspected cardiomyopathy. P4HB scaffold and PP mesh were subcutaneously and peri-vaginally implanted into the rabbit abdomen and vagina respectively. All rabbits had both posterior and anterior vaginal implants, and half of the rabbits had four abdominal implants in addition to the vaginal implants. The abdominal implants were 4.5 cm long × 1.5 cm wide whereas the vaginal implants were 1.5 cm long × 0.5 cm wide. At 3 and 9 months, gross necropsy was performed and samples were obtained, sectioned, stained and evaluated via histological analysis. Specimens were assessed for host inflammatory response, neovascularization, elastin content, and collagen deposition/maturation. Specimens were also biomechanically evaluated via uniaxial tensile test to determine the stiffness, ultimate tensile strength and load at ultimate tensile strength of the device/tissue composite. RESULTS: No abdominal mesh exposures were noted. A comparable number of asymptomatic partial vaginal exposures were observed at 3 months (P4HB: n = 3; PP: n = 2) and 9 months (P4HB: n = 3; PP: n = 2) respectively. Histological analysis of specimens showed comparable results in the P4HB and PP groups at 3 and 9 months post-implantation. Although no acute inflammation was seen, chronic inflammation was demonstrated in all specimens. Elastic fibers were present in the 3-month vaginal PP and P4HB specimens, but were not seen again. There was an increase in type I/III collagen noted over time. Biomechanical evaluation of the vaginal mesh tissue complex showed ultimate tensile strength was not significantly different between P4HB and PP groups at 3 (P = 0.625) and 9 months (P = 0.250) respectively. CONCLUSIONS: P4HB scaffold may represent a fully absorbable alternative to permanent mesh for pelvic organ prolapse (POP) repair.

Prevalence of stress urinary incontinence and intrinsic sphincter deficiency in patients with stage IV pelvic organ prolapse.

AIM: To determine the prevalence of stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD) in women with stage IV pelvic organ prolapse. METHODS: Retrospective analysis of women with stage IV prolapse who underwent multichannel urodynamic testing. Abdominal leak point pressures (ALPP) and maximum urethral closure pressures (MUCP) were recorded. ISD was defined as ALPP ≤60 cm of water and/or MUCP ≤20 cm of water. Percentages were used to present the proportion of subjects diagnosed with SUI and ISD. RESULTS: A total of 145 patients met inclusion criteria. Mean age was 69 years; most patients were Caucasian (56%). Eighty-two (56%) patients were found to have SUI on urodynamic testing. Thirty-six (44%) of these were asymptomatic and identified as having occult SUI. Sixteen (19.5%) patients were diagnosed with ISD using ALPP and/or MUCP. Six (37%) of the ISD patients had at least one MUCP value ≤20 cm of water and 12 (75%) had observed leakage with at least one ALPP value ≤60 cm of water. The number of patients with leakage at ALPP ≤60 cm of water increased with increasing bladder volumes. Five ISD patients (31%) had ALPP ≤60 cm of water at 200 mL, six (37.5%) had ALPP ≤60 cm of water at 300 mL and seven (43.8%) had ALPP ≤60 cm of water at 400 mL. CONCLUSION: Greater than 50% of patients with stage IV pelvic organ prolapse had SUI on urodynamic testing, and 20% were found to have ISD. Of the patients diagnosed with SUI, 40% were asymptomatic. These findings may assist in counseling and preoperative planning for women with stage IV prolapse.

#Urogyn: What's Trending on Instagram? A Cross-sectional Observational Study.

OBJECTIVE: The aim of the study was to identify the prevalence, authorship, and type of information pertaining to topics in urogynecology on Instagram via hashtag and content analysis. METHODS: A list of 20 hashtags consisting of common urogynecologic diagnoses, procedures, and lay terms was derived from the American Urogynecologic Society's "Patient Fact Sheets." The top 9 and most recent 30 posts for each hashtag were reviewed for authorship and content type. Content type was divided into the following categories: educational; tagged but unrelated posts; pertinent patient experiences; community building and outreach; advertisements; and humor. Searches were limited to English language posts. RESULTS: Our search yielded 561,133 posts. The 5 most popular hashtags were pelvic floor (30.6%, n = 171,855), interstitial cystitis (12.8%, n = 71,977), pelvic pain (10.0%, n = 56,505), incontinence (9.3%, n = 52,169), and prolapse (3.9%, n = 21,839). The authorship of the top 9 and most recent 30 posts (n = 537) were as follows: patients (34.6%, n = 186), allied health professionals (29.2%, n = 157), physicians (13.4%, n = 72), and other (22.7%, n = 122). Further authorship and content analysis revealed that allied health professionals authored the most informational posts (45.6%, n = 129) and patients authored the most unrelated (69.4%, n = 43), patient experience (81.7%, n = 125), community building (55.8%, n = 53), and humorous posts (38.5%, n = 10). CONCLUSIONS: More than 500,000 posts related to urogynecology were identified on Instagram. Most posts were authored by patients and allied health professionals with a small contribution from physicians. Greater physician participation may increase the quantity of educational posts and offer a low-cost platform for networking and connecting with patients and other providers.

Comparing Force of Stream With a Standard Fill Voiding Trial After Surgical Repair of Apical Prolapse: A Randomized Controlled Trial.

OBJECTIVE: To estimate whether the urinary force of stream method is noninferior to a standard fill voiding trial for rate of catheterization within 6 weeks after apical prolapse surgery in those discharged without a catheter. METHODS: A noninferiority randomized controlled trial was conducted in postoperative women comparing force of stream with standard fill voiding trials after vaginal, abdominal, or laparoscopic-robotic apical pelvic organ prolapse (POP) surgery. Before discharge, women in both groups were backfilled with 300 mL normal saline. Successful voiding criteria in the force of stream group was subjective force of stream of at least 50 using a visual analog scale; reporting less than 50 prompted a bladder scan. Successful voiding was defined as a postvoid residual volume of less than 500 mL. For the standard fill voiding trial group, voiding two thirds of the instilled amount indicated success. The primary outcome was the rate of catheterization within the 6-week postoperative period after surgical repair of apical prolapse among those discharged without a urinary catheter. Secondary endpoints included trial of void failure rates. A sample size of 59 patients per group who passed trial of void at discharge was needed to achieve 80% power using a noninferiority margin (delta of 10%). Total enrollment of 169 patients was necessary to account for an estimated 30% trial of void failure rate. RESULTS: From April 2016 and April 2017, 184 patients were enrolled (six enrolled before the trial registration date), with the first patient enrolled on April 1, 2016. One hundred seventy-four patients were randomized (86 in the force of stream group and 88 in the standard fill voiding trial group). No differences were observed in demographic or perioperative characteristics, except for stage 2 apical prolapse (52% in the force of stream group vs 36% in the standard fill voiding trial group). For the primary outcome, similar rates were found in those patients who passed their trial of void but subsequently needed catheterization for voiding dysfunction (force of stream 2.8% [2/71] vs standard fill voiding trial 3.1% [2/64]; difference -0.3%, 95% CI -8.69% to 8.08%). The incidence of trial of void failures at discharge was similar (force of stream 17.4% [15/86] vs standard fill voiding trial 26.4% [23/87]; risk ratio 0.65, 95% CI 0.37-1.18, P=nonsignificant). CONCLUSION: Force of stream was noninferior to standard fill voiding trial when comparing the rate of catheter insertion during the 6-week postoperative period after apical POP surgery in those discharged without a catheter. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02753920.

A randomized controlled trial comparing two voiding trials after midurethral sling with or without colporrhaphy.

INTRODUCTION AND HYPOTHESIS: To compare the force of the stream (FOS) voiding trial with the standard voiding trial (SVT) after outpatient midurethral sling (MUS) whether or not colporrhaphy was performed. METHODS: This is a randomized controlled non-inferiority trial of patients scheduled for MUS or colporrhaphy. Sample size of 102 patients was calculated for 80% power. Patients were randomized to FOS or SVT. Primary outcome was the number of unexpected postoperative visits (UPOVs) for voiding dysfunction (VD) or urinary tract infection (UTI). Voiding dysfunction was defined as urinary retention or post-void residual (PVR) > 200 cc. Subjects rated FOS using a visual analog scale (VAS). Criterion for non-inferiority was an upper limit of < 10% for the 95% CI. Analyses were performed using SAS version 9.4 (SAS Institute. Cary, NC). RESULTS: One hundred two subjects were included (49 FOS, 53 SVT). Immediate postoperative catheterization for FOS and SVT was 8.2% (n = 4) and 9.4% (n = 5), respectively. Recovery time was significantly less for FOS versus SVT (p = 0.0002). Total UPOVs were five (10.2%) and two (3.8%) for FOS and SVT, respectively. Two FOS subjects who had MUS + colporrhaphy passed their VT and had subsequent UPOVs for VD. No evidence of non-inferiority was noted when comparing FOS to SVT for total UPOVs: CI: 6.0% (-5.2, 17.2) for postoperative VD [CI: 6.1% (-4.0, 16.2)] or UTIs [CI: 0.3% (-9.4, 10.1)]. CONCLUSIONS: No evidence of non-inferiority was noted comparing FOS with SVT for unexpected postoperative visits for voiding dysfunction or UTI. This study shows the need for larger studies to assess the use of the FOS method in patients undergoing surgery for prolapse with or without MUS.

Nonsurgical Treatment Options for Women With Pelvic Organ Prolapse.

Pelvic organ prolapse is a medical condition that can cause pelvic discomfort as well as urinary and bowel complications. Approximately 25% of women in the United States and roughly 50% of women worldwide develop this condition. Although pelvic organ prolapse is usually a non-life-threatening condition, it can result in decreased self-confidence and negative body image. Physical and emotional sequelae can limit physical activity, and decreased productivity could be a consequence. Evidence from the literature indicates that pessary use and pelvic floor muscle training are effective options when conservative treatment is desired. Additional research is necessary to determine long-term outcomes in women who choose nonsurgical treatments. Nonsurgical options are important for women for whom surgery is contraindicated or not preferred.

Robotic-assisted Sacrocolpopexy with versus without Concomitant Midurethral Sling: A 2-year Follow-up of Urinary Symptoms and Quality of Life.

OBJECTIVE: The objective of this study was to assess long-term postoperative urinary incontinence (UI) symptoms and quality of life (QOL) in patients after robotic-assisted sacrocolpopexy (RASC) with or without concomitant midurethral sling (MUS). MATERIALS AND METHODS: This is a cross-sectional survey of patients comparing long-term postoperative urinary symptoms and QOL measurements in women who underwent RASC with or without MUS. We included all patients from 2011 to 2014 who had RASC with or without MUS. All patients had preoperative urodynamic testing (UDS). Patients who demonstrated stress UI on UDS underwent MUS at the time of RASC. Urinary symptoms and QOL were assessed through the validated Urinary Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7) patient questionnaires. RESULTS: Sixty-eight patients met inclusion criteria, 46 patients completed follow-up questionnaires, and were included in the final analysis. Average length of time to follow-up from surgery was 24 months (range: 6-36 months). A statistically significant difference in UDI-6 scores between the two groups (RASC vs. RASC + MUS) was observed. Median (25th and 75th percentiles) scores for UDI-6 were 22.92 (8.33 and 32.29, respectively) for the RASC group and 4.17 (0 and 13.54, respectively) for the RASC + MUS group (P = 0.0017). Median scores for IIQ-7 were 0 (0 and 29.73 for the 25th and 75th percentiles, respectively) for the RASC group and 0 (0 and 0, respectively) for the RASC + MUS group (P = 0.1691). CONCLUSION: Patients who underwent RASC + MUS scored significantly lower on the UDI-6, indicating fewer urinary distress symptoms. Although not statistically significant, patients in the RASC + MUS group had lower IIQ-7 scores, indicating less negative impact on QOL, compared to the RASC-only group.

Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

OBJECTIVES: The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. METHODS: The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. RESULTS: A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). CONCLUSIONS: In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.

Inflammatory Urinary Cytokine Expression and Quality of Life in Patients With Overactive Bladder.

OBJECTIVE: The aims of this study were to analyze levels of selected inflammatory urinary cytokines/chemokines in subjects with overactive bladder (OAB) and to determine if cytokine/chemokine levels correlate with quality of life and symptom distress. METHODS: This prospective, case-control pilot analysis included 23 women with OAB and 22 control subjects. Overactive bladder subjects were enrolled if they had symptoms of urinary frequency, urgency, or urge incontinence for more than 3 months and urodynamic evidence of detrusor overactivity. Control subjects denied urinary symptoms. Subjects and control subjects were excluded if they had known inflammatory bladder or systemic conditions, cystitis, stones, or recent anticholinergic use. Urine samples were collected from each subject and control. Subjects filled out the Incontinence Quality of Life Questionnaire and the Urinary Distress Inventory Questionnaire 6. Cytokine/chemokine levels were determined using the multiplexed Meso Scale Discovery Platform and were corrected for urinary creatinine concentrations. Statistical analysis comparing cytokine/chemokine levels was performed using the Mann-Whitney U test; relationships between cytokine/chemokine and questionnaire scores were calculated with Spearman correlation coefficient. RESULTS: Subjects with OAB had significantly lower urinary interleukin 10 (IL-10), IL-12-p70, and IL-13 levels compared with control subjects. Interleukin 1 correlated with worsening symptom distress on Urinary Distress Inventory Questionnaire 6. CONCLUSIONS: To our knowledge, this is at present the only study correlating inflammatory cytokine/chemokine levels in women with OAB with quality of life and distress. Interleukin 1 signified worsening distress, whereas IL-10, IL-12p70, and IL-13 were the only cytokines found at different levels in subjects. Our findings support a larger study in order to evaluate the value of urinary cytokines/chemokines as potential biomarkers.

Faecal incontinence: a narrative review of clinic-based management for the general gynaecologist.

The objective of this article is to provide an informative and narrative review for the general Gynaecologist regarding the pathophysiology and conservative treatments available for faecal incontinence (FI). A PubMed search was performed by library staff and an author using the keywords: anal incontinence, faecal incontinence, accidental bowel leakage, outpatient clinic management of faecal incontinence and defecatory dysfunction. As the social limitations of FI can be devastating and long-term patient satisfaction rates after anal sphincteroplasty remain reportedly-low, the role of clinic-based management of FI has continued to grow. The purpose of this article is to provide the Obstetrician and Gynaecologist with a basic template for screening, evaluation and management of faecal incontinence in the clinical setting.

Putting POP-Q to the test: does C - D = cervical length?

INTRODUCTION AND HYPOTHESIS: We investigated the correlation between calculated cervical length (CCL) and gross specimen cervical length (GCL) after total vaginal hysterectomy (TVH) at the time of surgery for pelvic organ prolapse (POP). METHODS: This was a retrospective chart review of patients who had undergone TVH with reconstructive surgery for POP between 2013 and 2015. Patients without an intact specimen or documented cervical length in the pathology report were excluded. CCL was defined as the absolute difference between Pelvic Organ Prolapse Quantification (POP-Q) points C and D. GCL was obtained from the pathology report as the distance from the external to the internal os. The Bland-Altman method was used to assess the accuracy of POP-Q measurements with a priori ranges. Symptom severity was evaluated using the PFDI-20 questionnaire. Analysis of variance was used to model both GCL and CCL as a function of prolapse stage and the leading compartment. RESULTS: The final analysis included 202 subjects. Of the CCL measurements, 56.93% were within ±2 cm of GCL, while 36.14% were within ±1 cm. POP stage was significantly associated with GCL (P < 0.0024). CCL was significantly longer in patients with stage 4 POP (3.57 cm, 95% CI 3.13-4.00) than in those with stage 2 POP (P < 0.0017; mean 2.68 cm, 95% CI 2.45-2.92) and stage 3 POP (P < 0.0300; mean 2.94 cm, 95% CI 2.73-3.15). There were no significant correlations between PFDI scores and CCL or GCL. CONCLUSIONS: The agreement between POP-Q CCL (|C - D|) and GCL decreases with increasing POP-Q stage. There was no correlation between POP symptom severity and GCL or CCL. GCL significantly increased with increasing POP stage.

Comparison of strength of sacrocolpopexy mesh attachment using barbed and nonbarbed sutures.

INTRODUCTION AND HYPOTHESIS: We aimed to assess the pull-out strength of barbed and nonbarbed sutures used in sacrocolpopexy mesh fixation. We hypothesized there are no differences in the force needed to dislodge mesh from tissue using barbed and nonbarbed sutures of similar size. METHODS: Using the rectus fascia of three unembalmed cadavers, a 6 × 3 cm strip of polypropylene mesh was anchored to the fascia with sutures. The barbed sutures investigated were 2-0 V-Loc 180 (nine trials) and 3-0 bidirectional Quill™ SRS PDO (five trials). The nonbarbed sutures included 2-0 PDS (nine trials), CV-2 GORE-TEX (nine trials) and 2-0 Prolene (nine trials). The free-end of the mesh was anchored to a pulley system fixed to a tensiometer to measure the peak force applied at the moment of mesh dislodgement (termed the pull-out force). The pull-out force was recorded. Continuous variables are presented as medians and interquartile ranges (IQR). Analysis of variance was used to compare the forces across the suture types. RESULTS: The highest pull-out force observed was with GORE-TEX (median 65.14 N, IQR 53.37-68.77 N) followed by Prolene (median 58.98 N, IQR 54.64-62.59 N), V-Loc (median 55.23 N, IQR 51.60-58.57 N), PDS (53.96 N, IQR 51.60-57.88 N), and Quill (44.44 N, IQR 17.27-47.38 N). All 2-0 and CV-2 caliber sutures had greater pull-out forces than 3-0 Quill sutures (p < 0.01). No significant differences in pull-out forces were observed between 2-0 and CV-2 caliber sutures (p > 0.05). In 35 of the 41 trials (85%), the mesh sheared from the tissue. CONCLUSION: CV-2 ad 2-0 barbed and nonbarbed sutures had similar pull-out forces in an assessment of mesh fixation strength.

The prevalence of microscopic hematuria in a cohort of women with pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: In 2012, the American Urological Association (AUA) revised its guidelines for microscopic hematuria (MH). We hypothesize that the prevalence of MH is greater in women with pelvic organ prolapse than in the general population. METHODS: All patients presenting to an outpatient urogynecological center with prolapse between January 2008 and December 2011 were reviewed. Exclusion criteria included: pregnancy, presence of gross hematuria, menses, or urological pathology. MH was defined as ≥3 red blood cells per high power field on one urinalysis specimen with a negative urine culture, and the prevalence of MH was calculated. Statistical analysis was performed. RESULTS: One thousand and forty women with pelvic organ prolapse were included in the analysis. Mean age was 64.1 years (range 20 to 96) and mean parity was 2.7 (range 0 to 12). Two hundred and nine out of 1,040 met the criteria for MH. No cases of urological malignancy were diagnosed in patients who underwent further workup. One hundred and ninety-seven patients with MH (93.4 %) had cystoceles on examination. CONCLUSIONS: This is the largest study to investigate MH in women with prolapse based on the new guidelines. The prevalence of MH was 20.1 % in our study population. Cystoscopy, renal function testing, and CT urography are now recommended after one positive urinalysis, regardless of gender or the presence of prolapse. Owing to the low incidence of urological malignancy detected as well as the increased prevalence of MH found in women with prolapse, specific guidelines for the management of MH in this population are needed.

The effect of collection method on urinalysis results in women with pelvic organ prolapse.

Midstream clean catch and catheterized urine specimens were obtained for each patient and samples were compared by microscopic urinalysis. The results of this study demonstrate that a midstream clean catch does not yield accurate urinalysis results in women with advanced urogenital prolapse.