A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause.

BACKGROUND: Despite some prospective case series showing effectiveness of vaginal laser to treat genitourinary syndrome of menopause (GSM), there is a paucity of placebo-controlled level one evidence. AIM: To assess the effect of fractional carbon dioxide (CO2) laser therapy to treat GSM against a sham comparator. METHODS: We conducted a parallel, randomized, double-blind, sham-controlled trial to compare menopausal women treated with fractional CO2 laser against sham treatment for improvement in GSM-related dyspareunia. Three treatments were given 6 weeks apart, and participants attended a 6-month visit from study start for primary (proportion improved) and secondary (vaginal health index, VHI; visual analogue scale, VAS; modified global assessment, PGI-I; Female Sexual Function Index, FSFI; Day-to-Day Impact of Vaginal Aging, DIVA; Urinary Distress Inventory short-form, UDI-6) assessments. OUTCOMES: The primary endpoint was a 2-stage improvement in GSM-related dyspareunia from baseline to 6 months determined by a severity scale, and the proportion of subjects who achieved this were compared between groups. RESULTS: Thirty participants were randomized to laser (n = 14) or sham (n = 16). In the treatment arm, 13 attended all treatments, and 1 attended at least 2 while in the sham arm, 14 attended all treatments, and 2 attended at least 2 treatments. Twelve (86%) in the treatment arm and 16 (100%) in the sham arm attended the 6-month visit. There were no differences in the proportion improved between treatments and controls (64% vs. 67%, respectively, P = 1.000). Both arms showed significant within-group improvements based on VHI and VAS, but not between groups. Similar findings were observed on sexual impact questionnaires with improvements within both groups from baseline to 6 months but not by median differences between the groups at 6 months. There were no adverse events in either of the arms. CLINICAL IMPLICATIONS: Further well-powered research is needed to determine efficacy of fractional CO2 laser for the treatment of GSM, especially in light of a potential placebo effect. STRENGTHS & LIMITATIONS: We present a sham-controlled double-blinded randomized trial using validated tools; the main limitation included an underpowered proportion of sexually active participants for the primary outcome. CONCLUSION: This study was underpowered to draw conclusions regarding the efficacy of fractional CO2 laser therapy in the treatment of GSM. We did observe improvements in the sham-arm to suggest a possible placebo contribution. Further well-powered level one research is needed to demonstrate the therapeutic effect of this novel modality. Cruff J, Khandwala S, A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause. J Sex Med 2021;18:761-769.

Prospective analysis of transvaginal mesh hysteropexy in the treatment of uterine prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the efficacy of using transvaginal mesh to correct uterine prolapse by hysteropexy. METHODS: This was a single-center, prospective study of 40 subjects with bothersome uterine prolapse. Inclusion criteria were bothersome perception of a vaginal bulge on Pelvic Floor Distress Inventory short form (PFDI-20) and having a Pelvic Organ Prolapse Quantification System (POP-Q) point C of -2 or worse. Exclusionary criteria included inability to consent, history of pelvic malignancies, or any prior prolapse repair. Eligible subjects were treated with transvaginal mesh hysteropexy between March 2016 and July 2018 for a primary outcome of composite success, which was defined by a POP-Q point C value of -2 or higher, PFDI-20 question 3 indicating no bothersome perception of prolapse, and no retreatment. Secondary outcomes included responses to condition-specific and quality-of-life questionnaires, satisfaction/regret, and complications. RESULTS: Transvaginal mesh hysteropexy was performed in 40 subjects. The majority (68%) had advanced stage (III/IV) uterine prolapse. At a median follow-up of 12 months, there was an 84% composite success, and considering only anatomic criteria (POP-Q point C < -1), there was a 92% success. No subject required reintervention for recurrent or persistent uterine prolapse. There were no cases of mesh exposures. In terms of safety, one subject required a blood transfusion for symptomatic anemia (Clavien-Dindo grade II), and one subject reported de novo dyspareunia from a perineal band that was released in office at 6 months (grade IIIa), but otherwise there were no serious immediate or late complications. There were significant improvements in both condition-specific and quality-of-life assessments from baseline. Subject satisfaction and acceptance for the procedure were high. CONCLUSIONS: In this single-center case series of 40 women with bothersome uterovaginal prolapse, transvaginal mesh hysteropexy appears safe and effective for correcting advanced stage uterine prolapse at the short term. A future multicenter controlled trial would be needed to determine efficacy against native tissue repair.

The Role of Yoga in the Management of Bladder Pain Syndrome: A Single-Arm Pilot Study.

BACKGROUND: Bladder pain syndrome (BPS) is a devastating urologic condition characterized by irritative bladder symptoms, pelvic pain, and dyspareunia. First-line treatment includes dietary, self-care and behavioral modifications. The ancient practice of yoga is well suited to treat BPS, but evidence is lacking on its use. AIMS: To investigate the feasibility and efficacy of an integrated yoga module on BPS outcomes as measured by self-reported questionnaires from baseline to 3 months after therapy. METHODS AND MATERIALS: This was a prospective single-arm study of 8 patients who underwent 3 months of integrated yoga therapy. The treatment module was performed 3 to 4 times weekly at home with 1 session performed weekly in-office during the first month to ensure proper performance of postures. Patients completed questionnaires (Pelvic Pain and Urgency/Frequency Patient Symptom Scale [PUF], Pelvic Floor Impact Questionnaire - short form 7 [PFIQ-7], Short Form 36 questionnaire [SF-36], Pittsburgh Sleep Quality Index [PSQI]) at baseline and 3 months, including Patient Global Impression of Improvement (PGI-I) at the 3-month follow-up visit. Voiding diaries were also requested at baseline and at the 3-month assessment. RESULTS: There was a trend toward improvement regarding patients' responses to all questionnaires 3 months after yoga therapy, with the only statistically significant improvements noted in social function and pain components of the SF-36. There were no significant changes noted on the voiding diaries except a non-statistically significant trend toward increased voided volumes. Patients rated their experiences with yoga therapy positively. CONCLUSIONS: Yoga therapy for BPS showed evidence of benefit for improving bothersome bladder symptoms, pain and voiding. A randomized controlled trial will follow to investigate the efficacy of this yoga module against a control group.

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

A randomized trial of urodynamic testing before stress-incontinence surgery.

BACKGROUND: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Role of vaginal mesh hysteropexy for the management of advanced uterovaginal prolapse.

OBJECTIVE: To determine the role of vaginal mesh hysteropexy in the management of advanced genital organ prolapse as assessed by subjective and objective parameters. STUDY DESIGN: Retrospective case series of 77 women followed for at least 1 year after vaginal mesh hysteropexy performed for stage III or greater uterovaginal prolapse. The primary outcome was Pelvic Organ Prolapse Quantification (POP- Q) stage < II and no subjective bothersome bulge and no further interventions for prolapse. Secondary outcomes assessed were complications such as intraoperative bleeding, injuries, and postoperative complications such as mesh exposure, mesh retraction, dyspareunia, urinary incontinence, and voiding dysfunction. RESULTS: Mean follow-up was 13.7 +/- 4.1 months. Our composite success score was 85.7%. The anatomic (POP-Q) success score was 90.9%. Most failures (all but 1) were stage II with cervix as leading edge. Incidence of de novo dyspareunia was 3.7% and vaginal mesh erosion was 6.5%. Most patients 68/77 (88.3%) were discharged home voiding normally. CONCLUSION: Vaginal mesh hysteropexy offers good success; however, comparative studies are required to validate its true role.

Retropubic versus transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Three-year Follow-up of a Single Incision Sling Procedure Performed Under Local Anesthesia in an Office Setting.

OBJECTIVE: To assess the 3-year success of placing a single-incision midurethral sling (SIMS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. METHODS: This is a prospective case series of 20 women who underwent in-office SIMS procedure by the DISST from July 2019 to February 2020. This is an extension of our pilot study (11) and all 20 patients were evaluated at a mean follow-up of 34.3months. Success was defined as a composite score of objective success (negative standing cough test at bladder fullness), subjective success based on the modified PGI-I score of "very much better" or "much better," and no retreatment for stress urinary incontinence. Secondary objectives were adverse events, de novo overactivity of the bladder, recurrent urinary tract infections, voiding dysfunction, pain/dyspareunia, and influence on sexual function. RESULTS: The composite success rate was 95% (95% CI [75.1, 99.9]) at the 36-month follow-up. The significant improvement in MESA scores was maintained over the study period. There were no cases of de novo urgency, mesh exposure, postop voiding dysfunction or recurrent urinary tract infections. There were no cases of de novo dyspareunia. CONCLUSION: SIMS placed by the DISST technique under local anesthesia in an office setting has shown sustained efficacy over a 3-year period with no decrease in cure. Subjects remained dry and reported excellent improvement in symptoms and quality of life at the 36-month follow-up visit.

The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women.

PURPOSE: We examined the clinical effectiveness of a single incision sling in women with stress urinary incontinence and obtained comparative perioperative and postoperative data on retropubic and transobturator slings. MATERIALS AND METHODS: Women who underwent a cough stress test were treated with surgery using a single incision, retropubic or obturator sling (Gynecare® TVT SECUR™, TVT™ or TVT Obturator System, respectively) with the choice of sling based on surgeon preference. Objective cure was assessed by the standing cough stress test at 1 year. Subjective outcomes were assessed by the Incontinence Quality of Life Questionnaire and EQ-5D™. Perioperative data and return to normal activity were recorded. RESULTS: Of the 1,398 women who underwent surgery there were postoperative data on 1,334, including 32.8%, 17.8% and 49.4% who received a tension free vaginal tape, obturator tension free vaginal tape and SECUR, respectively. After obturator tension free vaginal tape surgery fewer women had a positive cough stress test than after TVT and SECUR surgery (4 of 110 or 3.6% vs 24 of 187 or 12.8% and 59 of 374 or 15.8%, respectively). Incontinence Quality of Life Questionnaire effect size was 1.87, 1.42 and 1.56, respectively, indicating a large treatment effect. Using our Incontinence Quality of Life Questionnaire response definition 85.4%, 79.0% and 85.2% of the TVT, TVT outside-in obturator system and SECUR cohorts, respectively, were treatment responders (p = 0.11).The SECUR cohort had the shortest operative time, the lowest proportion of women who required an overnight stay and the most women who underwent surgery under local anesthesia. Median time to return to employment, housework, sex life and hobbies was most rapid for SECUR. CONCLUSION: This registry demonstrates the high effectiveness of all 3 approaches. The single incision sling appeared to have objective and subjective efficacy similar to that of the retropubic sling and it can be performed under local anesthesia in an office environment.

Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial.

INTRODUCTION AND HYPOTHESIS: This study deals with assessment of safety, efficacy, and potential complications of Prolift+M system to correct uterovaginal prolapse. METHODS: We analyzed a prospective cohort treated with the Gynecare PROLIFT+M mesh system between October 2008 and March 2010. A composite score that included subjective/objective cure and lack of complications was used to assess treatment success. RESULTS: One hundred sixty-seven women (age 65.1 ± 11.2 years, BMI 29.2 ± 5.8 kg/m(2)) were treated for pelvic organ prolapse using the PROLIFT+M system. Seven anterior Prolift+M, 42 posterior Prolift+M, and 118 total Prolift+M mesh surgeries were performed in patients with stage II or greater degrees of prolapse. Mean operative time was 122.7 ± 43.9 min. Mean intraoperative blood loss was 119.4 ± 125.3 ml. Our composite success score was 72.5% (treatment failures per POP-Q stage 1.4%, perception of bulge 4.4%, erosions 3.6%, pain/dyspareunia 3.7%, incontinence 0.7%, de novo urge urinary incontinence 8.7%, voiding dysfunction 0.6%, recurrent urinary tract infection 2.2%, and anal incontinence 2.2%). CONCLUSIONS: Prolift+M surgery is safe and effective with minimal postoperative morbidities.

Single-incision Midurethral Sling by the Dynamic Intraoperative Standing Sling Technique as an Office-based Procedure: A Pilot Study.

OBJECTIVES: To assess the safety, feasibility, and short-term success of placing Solyx (Boston Scientific, Marlborough, MA) single-incision midurethral sling (SIMUS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. METHODS: The safety and efficacy of the in-office Solyx DISST procedure for treatment of stress urinary incontinence was assessed 6 months from the procedure. Improvement in stress urinary incontinence was measured using validated questionnaires (Medical, Epidemiologic, and Social Aspects of Aging, MESA; Incontinence Impact Questionnaire-7, IIQ-7; Pelvic Organ Prolapse/Urinary Incontinence Sexual Function, PISQ-12) and by a negative standing provocative stress test. Postoperative complications were documented along with subjective pain diaries, return to work/activities, and overall satisfaction. RESULTS: From July 2019 through February 2020, 20 subjects underwent in-office Solyx procedure by the DISST technique. Six of the 20 (30%) subjects required intraoperative sling adjustments. There were no complications as related to the office-based procedure. Participants reported a favorable intraoperative experience. Subjects had excellent postoperative pain control and early return to work and normal activities. At 6 months, all 20 subjects had negative standing provocative stress tests, showed statistically significant improvements on MESA, IIQ-7, and PISQ-12, and reported high satisfaction and acceptance for the procedure and outcomes. There were no late (>6 weeks) complications associated with the Solyx procedure. CONCLUSIONS: It appears safe and feasible to perform Solyx SIMUS by the DISST method in the office. Subjects remained dry and reported excellent improvement in symptoms and quality of life 6 months from surgery.

Retrospective Analysis of Sexual Function After Transvaginal Mesh Surgery.

INTRODUCTION: Despite ample research regarding the impact of reconstructive surgery on anatomic/functional outcomes of pelvic organ prolapse (POP), including incidence of dyspareunia, evidence regarding sexual outcomes is equivocal. AIM: To assess changes in sexual function in women followed up for at least 12 months after transvaginal mesh surgery for POP. METHODS: We conducted a retrospective review of women who underwent surgery for POP using different mesh products between 2008 and 2019. Baseline demographics were compiled along with intraoperative and postoperative information. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) was used to assess sexual function. MAIN OUTCOME MEASURES: Women sexually active before and after surgery were assessed to determine changes in overall and question-specific PISQ-12 responses and potential factors to explain sexual function after surgery. RESULTS: 622 women underwent surgery using mesh at our center. 360 (58%) attended at least one visit at a median of 12 months (IQR 11-23 months), with 113 (31%) sexually active at baseline and 247 (69%) sexually inactive. 97 had complete PISQ-12 responses before and after surgery. There was an overall improvement in the median PISQ-12 scores of 2 points (P < .001); improvements persisted when scores were stratified by various factors. Specific improvements were noted in climax (P = .046) and orgasm intensity (P = .002), fear (P < .001) or actual incontinence during intercourse (P = .004), avoidance of intercourse due to prolapse (P < .001), and negative emotions (P < .001). There was a slight positive effect of the baseline PISQ-12 score on the postoperative PISQ-12 score (regression coefficient 0.24, 95% CI: 0.09-0.39), and a stronger negative effect of having a concomitant anal sphincteroplasty (-4.84, 95% CI: -8.42 to -1.25). Preoperative prolapse stage was not associated with postoperative sexual outcomes. There was a weak negative association between the postoperative PISQ-12 and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) scores [rs(95) = -0.27, P = .008] and a moderate negative association between postoperative PISQ-12 and total Pelvic Floor Distress Inventory short form [rs(94) = -0.42, P < .001]. CONCLUSION: Transvaginal mesh surgery appears to positively impact sexual function, and improvements were independent of mesh or baseline prolapse severity. Khandwala S, Cruff J, Williams C. Retrospective Analysis of Sexual Function After Transvaginal Mesh Surgery. Sex Med 2021;9:100281.

Experience with TVT-SECUR sling for stress urinary incontinence: a 141-case analysis.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to investigate complications, urinary incontinence symptoms, and overall satisfaction in patients undergoing the tension-free vaginal tape-SECUR (TVT-S) for stress urinary incontinence (SUI). METHODS: We reviewed consecutive patients treated with TVT-S between April, 2006 and August, 2007, in a urogynecology practice. Outcomes assessed included complications, voiding function, change in SUI symptoms on the Medical Epidemiological and Social Aspects of Aging (MESA) questionnaire, and overall satisfaction. RESULTS: One hundred forty-one women (age, 54.1 +/- 12 years; BMI, 31.2 +/- 6.6 kg/m(2)) were treated for SUI with the TVT-S; 34 required concomitant procedures. There were no intra-operative complications. Immediate post-operative voiding function returned in all but one patient; none required sling release. Most patients (90%) reported no pain on a verbal pain scale. On follow-up, 117 patients denied SUI symptoms, 16 reported mild symptoms, and eight required additional treatment. The average MESA "stress" subscore decreased by 79% (13.0 +/- 7.8 points, p < 0.0001). Eighty-five percent felt "satisfied" with the procedure. CONCLUSION: TVT-S is a safe and effective treatment for SUI.

Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial.

BACKGROUND: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. OBJECTIVE: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. DESIGN: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. SETTING: 9 university-affiliated outpatient clinics. PATIENTS: 307 women with urge-predominant incontinence. INTERVENTION: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. MEASUREMENTS: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. RESULTS: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). LIMITATIONS: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. CONCLUSION: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

A Prospective Study to Evaluate Efficacy Using the Nuro Percutaneous Tibial Neuromodulation System in Drug-Naïve Patients With Overactive Bladder Syndrome.

OBJECTIVE: To evaluate changes from baseline in urgency urinary incontinence episodes, urinary frequency and quality of life through 12 weeks of percutaneous tibial neuromodulation (PTNM) therapy using NURO in drug-naïve overactive bladder syndrome (OAB) subjects. METHODS: Eligible subjects underwent 12 weekly PTNM sessions with the NURO system. Changes in voiding symptoms were evaluated with bladder diaries from baseline through 12 weeks. Analyses were conducted for subjects with data at baseline and follow-up visits (sessions 1, 4, 8, and 12). Safety was evaluated through adverse events (AE) related to the device, procedure, and therapy. RESULTS: Of 154 subjects enrolled in the study,120 subjects met study criteria and received PTNM. The mean age was 64.8 years, mean duration of OAB diagnosis was 3.4 years and 86% female subjects. No subjects tried OAB medication prior to enrollment. At baseline, patients had 3.5 ± 2.5 (mean ± SD) UUI episodes/day. Statistically significant improvement in urgency urinary incontinence episodes from baseline was observed at each follow-up visit (P < .0001), with a reduction of 2.4 ± 2.1 episodes after session 12 from baseline. Subjects with urinary frequency at baseline had 11.5 ± 2.9 voids/day. After session 12, a statistically significant reduction of 1.7 ± 2.5 voids/day was observed (P < .0001). Ninety-six percent (116/120) of subjects completed the study with diary data for the primary objective with an average of 11.6 sessions. There were no serious or unanticipated AEs. The most common AEs were medical device site pain (3.3%, 4/121) and extremity pain (3.3%, 4/121). CONCLUSION: PTNM using NURO is an effective and safe treatment for drug-naïve patients with OAB.

Transvaginal mesh surgery for pelvic organ prolapse: one-year outcome analysis.

OBJECTIVE: The aim of the study was to assess the role of Prolift + M (PP-PG) vaginal mesh surgery to correct uterovaginal prolapse not only from an anatomic but also a subjective (patient's) standpoint. METHODS: A prospective cohort of subjects treated with transvaginal mesh for prolapse between April 2009 and November 2010 was analyzed. A composite score that included subjective criteria of absence of a bothersome bulge and objective criteria based on Pelvic Organ Prolapse Quantification lower than stage II was used to assess treatment success. RESULTS: Transvaginal mesh was performed in 157 subjects (age, 64.7 ± 11.6 years; body mass index, 28.5 ± 4.8 kg/m) for pelvic organ prolapse. Five anterior mesh surgeries (3.2%), 48 posterior mesh surgeries (30.6%), and 104 total mesh surgeries (66.2%) were performed in subjects with stage II or greater degrees of prolapse. Stage II prolapse was noted in 44 subjects (28.0%), 91 subjects (58.0%) had stage III prolapse, and 22 subjects (14.0%) had stage IV prolapse. The mean follow-up was 13 months. Our composite success score was 88.1%. Pure anatomic success based on Pelvic Organ Prolapse Quantification lower than stage II was 94%. The mean operative time was 117.8 ± 42.4 minutes. The mean intraoperative blood loss was 106.1 ± 116.4 mL. There were 3 cases (2.2%) of mesh exposure in the vagina. There were no visceral injuries. The incidence of de novo dyspareunia was 6%. CONCLUSION: Transvaginal PP-PG mesh surgery is safe and effective with few postoperative morbidities.

TVT-Secur in office sling procedure under local anesthesia: a prospective 2-year analysis.

OBJECTIVE: Our objective was to assess long-term safety, feasibility, and success of performing single-incision mini-sling tension-free vaginal tape (TVT)-Secur (TVT-S) procedure in the office under local anesthesia for stress urinary incontinence. METHOD: Fifty subjects were enrolled from October 2008 to May 2009. The TVT-S procedure (Hammock approach) was performed per strict guidelines. Success was based on a composite score of 7 subjective and objective measures at 24 months. RESULTS: Success per the composite score was 80%. Retreatment for stress urinary incontinence was 9%. There was significant improvement in quality of life and symptom relief scores (P<0.001). Ninety-four percent were satisfied with the surgical outcome, and 98% felt they made the right decision. There were no intraoperative injuries or complications. Two subjects had mesh exposure in the vagina. CONCLUSION: In-office single-incision mini-sling TVT-S is safe, feasible, and successful with minimal complications; however, strict criteria need to be followed.