Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?

OBJECTIVES: There is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity. METHODS: This is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22. RESULTS: A total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138). CONCLUSIONS: In this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.

Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair.

OBJECTIVE: To assess independent risk factors for surgical failure and worsening pelvic floor symptoms within 5 years after vaginal prolapse surgery. METHODS: This secondary analysis includes OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) (n=374) and E-OPTIMAL (Extended) (n=285) trial participants. Surgical failure was defined as apical descent greater than one third of the total vaginal length, anterior or posterior vaginal wall past the hymen, subsequent surgery or bothersome vaginal bulge. Worsening pelvic floor symptoms were defined as increases from baseline as large as the minimally important difference for subscale scores of the Pelvic Floor Distress Inventory: 11 for the Urinary Distress Inventory and Colorectal-Anal Distress Inventory and 34.3 for the Pelvic Organ Prolapse Distress Inventory. Outcomes were measured at 6 months then 1, 2, 3, 4, and 5 years. Chi-square and t test results from bivariate models and clinical relevance were used to inform final models. RESULTS: Baseline risk factors for surgical failure were Hispanic ethnicity (adjusted odds ratio [aOR] 1.92, 95% CI 1.17-3.15), perineal body (aOR 1.34, 95% CI 1.09-1.63), and pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 1.16, 95% CI 1.05-1.28). Risk factors for worsening of pelvic floor symptoms were pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 0.75, 95% CI 0.60-0.94) for worsening Pelvic Organ Prolapse Distress Inventory score, vaginal deliveries (aOR 1.26, 95% CI 1.10-1.44) and pretreatment Urinary Distress Inventory score (aOR 0.86, 95% CI 0.80-0.93) for worsening Urinary Distress Inventory score, and age (aOR 1.03, 95% CI 1.01-1.05) and pretreatment Colorectal-Anal Distress Inventory score (aOR 0.95, 95% CI 0.92-0.98) for worsening Colorectal-Anal Distress Inventory score. CONCLUSIONS: Hispanic ethnicity, larger preoperative perineal body, and higher pretreatment Pelvic Organ Prolapse Distress Inventory scores were risk factors for surgical failure up to 5 years after vaginal prolapse repair. Participants with higher baseline Pelvic Floor Distress Inventory scores were less likely to worsen. Risk factors for worsening Urinary Distress Inventory and Colorectal-Anal Distress Inventory scores included more vaginal deliveries and increased age, respectively. CLINICAL TRIAL REGISTRATION: NCT00597935, NCT01166373.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence.

BACKGROUND: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. OBJECTIVE: The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. STUDY DESIGN: This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected. RESULTS: Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain. CONCLUSION: Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.

Female Pelvic Floor Immersive Simulation: A Randomized Trial to Test the Effectiveness of a Virtual Reality Anatomic Model on Resident Knowledge of Female Pelvic Anatomy.

STUDY OBJECTIVE: To estimate the effect of a virtual reality (VR) anatomic model (VisCubeSX; VisBox, Inc., Saint Joseph, IL) on obstetrics and gynecology residents' knowledge of female pelvic floor anatomy compared with a traditional curriculum. DESIGN: Randomized controlled trial (Canadian Task Force classification I). SETTING: Academic obstetrics and gynecology resident training program. INTERVENTIONS: Traditional independent study curriculum versus traditional curriculum and VisCubeSX VR curriculum MEASUREMENTS AND MAIN RESULTS: Residents were randomized, stratified by year of training, in a 1:1 fashion to traditional independent study curriculum for pelvic anatomy versus traditional curriculum and the VisCubeSX VR anatomic model. Tests were administered to assess baseline and postintervention knowledge. A postintervention assessment of the VisCubeSX VR anatomic model was performed. Baseline, follow-up, and score improvement were compared between groups using Student t tests and Wilcoxon rank sum tests. Thirty-one residents were randomized. There was a significant improvement in pre- and post-test scores within traditional independent study curriculum participants, 8.1 ± 12.0 points (p = .02), and the VisCubeSX group 8.7 ± 6.4 points (p <.001), but these improvements did not differ between groups (p = .86). This lack of between-group differences was consistent in resident year-stratified analyses. Residents exposed to the VisCubeSX VR anatomic model reported they "somewhat" or "strongly agree" (15/16 [93.8%] and 14/16 [87.5%] of residents, respectively) that the model improved their knowledge of pelvic anatomy and that the model will improve patient care. CONCLUSION: Few studies exist that compare educational outcomes of a traditional independent study of female pelvic anatomy curriculum versus immersive simulation with VR models in female pelvic anatomy. Knowledge scores were not significantly increased with the VR model compared with traditional curriculum, but VR technology was perceived as an enhancement to short-term learning.

Comparison of Vaginal Hysterectomy Techniques and Interventions for Benign Indications: A Systematic Review.

OBJECTIVE: To create evidence-based clinical practice guidelines based on a systematic review of published literature regarding the risks and benefits of available preoperative, intraoperative, and postoperative technical steps and interventions at the time of vaginal hysterectomy for benign indications. DATA SOURCES: We systematically searched the literature to identify studies that compared technical steps or interventions during the preoperative, intraoperative, and postoperative periods surrounding vaginal hysterectomy. We searched MEDLINE, Cochrane Central Register of Controlled Trials, Health Technology Assessments, and ClinicalTrials.gov from their inception until April 10, 2016, using the MeSH term "Hysterectomy, Vaginal" and associated text words. We included comparative studies, single-group studies, and systematic reviews published in English. METHODS OF STUDY SELECTION: We double-screened 4,250 abstracts, identifying 60 eligible studies. Discrepancies were adjudicated by a third reviewer. We followed standard systematic review methodology and the Grades for Recommendation, Assessment, Development and Evaluation approach to evaluate the evidence and generate guideline recommendations. TABULATION, INTEGRATION, AND RESULTS: Because of limited literature, only 16 perioperative risks, technical steps, and interventions were identified: obesity, large uteri, prior surgery, gonadotropin-releasing hormone agonists, vaginal antisepsis, bilateral salpingo-oophorectomy, morcellation, apical closure, uterine sealers, hemostatic injectants, hot cone, retractor, cystoscopy, vaginal packing, bladder management, and accustimulation. We organized and reported these as four domains: patient selection, preoperative, intraoperative, and postoperative. We did not identify any patient characteristics precluding a vaginal approach; chlorhexidine or povidone is appropriate for vaginal antisepsis; vasopressin decreases blood loss by 130 cc; tissue-sealing devices decrease blood loss by 44 cc and operative time by 15 minutes with uncertain complication implications; vertical cuff closure results in 1-cm increased vaginal length; either peritoneum or epithelium can be used for colpotomy closure; and routine vaginal packing is not advised. CONCLUSION: Minimal data exist to guide surgeons with respect to planning and performing a vaginal hysterectomy. This study identifies available information and future areas for investigation.

Preemptive analgesia for postoperative hysterectomy pain control: systematic review and clinical practice guidelines.

OBJECTIVE: The objective of the study was to investigate the effectiveness of preemptive analgesia at pain control in women undergoing total abdominal hysterectomy. DATA SOURCES: Eligible studies, published through May 31, 2016, were retrieved through Medline, Cochrane Central Register for Controlled Trials, and Cochrane Database of Systematic Reviews. STUDY ELIGIBILITY: We included randomized controlled trials with the primary outcome of pain control in women receiving a preemptive medication prior to total abdominal hysterectomy. Comparators were placebo, different doses of the same medication as intervention, or other nonnarcotic or narcotic medication. STUDY APPRAISAL AND SYNTHESIS METHODS: Study data were extracted by one reviewer and confirmed by a second reviewer. For each outcome we graded the quality of the evidence. Studies were classified by the type of medication used and by outcome type. RESULTS: Eighty-four trials met eligibility, with 69 included. Among nonnarcotic medications, paracetamol, gabapentin, and rofecoxib combined with gabapentin resulted in improvements in pain assessment compared with placebo and other nonnarcotic medications. Patient satisfaction was higher in patients who were given gabapentin combined with paracetamol compared with gabapentin alone. Use of preemptive paracetamol, gabapentin, bupivacaine, and phenothiazine resulted in less narcotic usage than placebo. All narcotics (ketamine, morphine, fentanyl) resulted in improved pain control compared with placebo. Narcotics had a greater reduction in pain assessment scores compared with nonnarcotics, and their use resulted in lower total narcotic usage. CONCLUSION: Preemptive nonnarcotic and narcotic medications prior to abdominal hysterectomy decrease total narcotic requirements and improve patient postoperative pain assessment and satisfaction scores.

Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation.

BACKGROUND: An existing model for fourth-degree laceration repair uses beef tongue with plastic or vinyl tubing. This modified model substitutes beef tripe for the anal mucosa and chicken leg muscles for the anal sphincter muscle analogs to create a realistic model. METHOD: Tripe is tunneled through the body of the trimmed beef tongue and sutured like an ostomy to simulate the anal canal. The tongue is incised toward the tripe "anal canal." Chicken leg muscles are tunneled from the incision out to the cut edges of the beef tongue to create anal sphincter muscle analogs. Procedures can be repeated on the opposite side. Two double-sided models can be made per tongue. EXPERIENCE: The model can be refrigerated or frozen and thawed before use. A fourth-degree laceration can be cut immediately before use. Materials were obtained at a local supermarket for $5-7 per half-tongue, double-sided model. Residents responded positively to the model and stated that animal tissue provided realistic haptic simulation. CONCLUSION: The modified beef tongue model utilizing tripe and chicken leg muscles as anal mucosa and anal sphincter muscle analogs, respectively, provided excellent perceived haptic fidelity. Moreover, it is an innovative, inexpensive, and well-received teaching tool to augment resident education.

Prevalence, Awareness, and Understanding of Pelvic Floor Disorders in Adolescent and Young Women.

OBJECTIVES: The objective of this study was to characterize symptom prevalence, awareness of pelvic floor disorders (PFDs) in family/friends, and understanding of factors contributing to the development of PFDs in women aged 19 to 30 years. METHODS: This study is a cross-sectional study via online questionnaire survey of female students aged 19 to 30 years enrolled at the University of Alabama at Birmingham. Results of "adolescent women" aged 19 to 24 years were compared with "young women" aged 25 to 30 years. RESULTS: A total of 1092 questionnaires were completed with the mean age being 23.5 ± 3.1 years. The overall rate of urinary incontinence (UI) was 10.3% without a difference between adolescent and young women (P = 0.61). There were no differences in rates of urgency UI (P = 0.061), stress UI (P = 0.29), or pelvic organ prolapse (POP) symptoms (P = 0.56) between groups. There was no difference between groups in awareness of family members with UI, fecal incontinence (FI), or POP symptoms (P ≥ 0.24). However, logistic regression showed that the young women were more likely to have received education regarding UI (adjusted odds ratio [aOR], 2.6; 95% confidence interval [CI], 1.8-3.6), FI (aOR, 3.3; 95% CI, 2.2-4.8), POP (aOR, 2.9; 95% CI, 2.1-4.2), and have greater understanding regarding causes of UI (aOR, 2.9; 95% CI, 1.7-4.8), FI (aOR, 1.6; 95% CI, 1.1-2.3), and POP (aOR, 1.9; 95% CI, 1.3-2.9). CONCLUSIONS: Women aged 25 to 30 years had more awareness and understanding of PFDs compared with adolescent women. These data may have implications for primary prevention strategies of PFDs.

Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment.

OBJECTIVES: The aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder (OAB) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy. METHODS: A single-site randomized, open-label trial in women with urinary frequency, urgency, nocturia, and/or urgency urinary incontinence symptoms was performed. Fifty-eight participants were randomized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week. The primary outcome was change in Overactive Bladder Questionnaire (OAB-q) symptom bother score at 12 weeks. Secondary outcomes included the Health-Related Quality of Life Questionnaire (HRQL) of the OAB-q and a 3-day bladder diary. At 12 weeks, subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks. RESULTS: There was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks (20.6 ± 21.7, -15.8 ± 23.3, respectively, P = 0.45). There was a significant within-group decrease in symptom bother score from baseline to 12 weeks (tolterodine, P < 0.0001, and intravaginal estradiol, P = 0.002). Secondary outcome improvement within groups was noted in the HRQL total, urinary incontinence episodes, and median voiding frequency (all P ≤ 0.03) in the tolterodine group and in the HRQL total score (P = 0.03) in the intravaginal estradiol group, with no differences between groups. Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks (20.0 ± 23.9, P = 0.008; -16.7 ± 23.3, P = 0.02, respectively). CONCLUSIONS: Significant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms, with no difference between groups. Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol. The role of combined medical therapy for OAB symptoms needs further investigation.

Synthetic Graft Augmentation in Vaginal Prolapse Surgery: Long-Term Objective and Subjective Outcomes.

OBJECTIVE: To report long-term objectives and subjective outcomes in women who underwent prolapse surgery with a synthetic graft augmentation. DESIGN: Retrospective analysis (Canadian Task Force classification II-3). SETTING: University hospital in the southeastern United States. PATIENTS: Women with symptomatic pelvic organ prolapse who underwent transvaginal graft augmentation using the Prolift mesh system between July 2006 and December 2008 for a minimum 5-year follow-up. INTERVENTIONS: Subjects completed the Pelvic Floor Distress Inventory (PFDI-20), the Pelvic Floor Impact Questionnaire (PFIQ-7), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), and the Patient Satisfaction Questionnaire. Subjects also underwent postoperative physical examination with Pelvic Organ Prolapse Quantification (POP-Q) and vaginal pain/stricture assessment. Long-term postoperative findings were compared with preoperative baseline data. MEASUREMENTS AND MAIN RESULTS: Of 208 eligible subjects, 70 completed the questionnaires only, and 48 of these 70 provided both postoperative examination and questionnaire data. The mean duration of follow-up was 7.0 ± 0.7 years (range, 5.8-8.1 years). POP-Q measurements of Ba (point B anterior), Bp (B posterior), C (cervix), GH (genital hiatus), PB (perineal body), and overall pelvic organ prolapse stage were significantly improved (all p < .001 except for PB, p = .006). PFIQ-7 (total, Urinary Impact Questionnaire, and Pelvic Organ Prolapse Impact Questionnaire) and PFDI-20 (total, Urinary Distress Inventory, and Pelvic Organ Prolapse Distress Inventory) scores significantly improved (all p < .001). No differences were noted in the colorectal-anal subscales (Colorectal-Anal Impact Questionnaire and Colorectal-Anal Distress Inventory) and PISQ scores at >5-year follow-up (all p > .05). Satisfaction rates were 15.7% for not at all, 35.7% for somewhat, and 48.6% for completely satisfied. Complications included graft exposure (n = 3; 6%) and dyspareunia (n = 25; 36%). CONCLUSION: Women undergoing transvaginal prolapse surgery using a synthetic graft continue to have positive objective and subjective outcomes, leading to significantly improved quality of life at a minimum 5-year follow-up.

Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman.

As population demographics continue to evolve, specifics on age-related outcomes of stress urinary incontinence interventions will be critical to patient counseling and management planning. Understanding medical factors unique to older women and their lower urinary tract conditions will allow caregivers to optimize surgical outcomes, both physical and functional, and minimize complications within this population.

Postoperative bowel function, symptoms, and habits in women after vaginal reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to characterize postoperative bowel symptoms in women undergoing vaginal prolapse reconstructive surgery randomized to preoperative bowel preparation vs a regular diet. METHODS: Subjects (N = 121) completed two bowel diaries: a 7-day bowel diary immediately before surgery and a 14-day diary postoperatively. Self-reported bowel diary data and symptoms included the time to first bowel movement (BM), daily number of BMs, Bristol Stool Form Scale score, pain, and urgency associated with BM, episodes of fecal incontinence, and use of laxatives. Antiemetic use was abstracted from medical records. Outcomes of groups were compared using Chi-squared/Fisher's exact test or Student's t test as appropriate. RESULTS: Mean time to first postoperative BM was similar in the bowel preparation (n = 60) and control groups (n = 61), 81.2 ± 28.9 vs 78.6 ± 28.2 h, p = 0.85. With the first BM, there were no significant differences between bowel preparation and control groups regarding pain (17.2 vs 27.9 %, p = 0.17), fecal urgency with defecation (56.9 vs 52.5 %, p = 0.63), fecal incontinence (14.0 vs 15.0 %, p = 0.88) and >1 use of laxatives (93.3 vs 96.7 % p = 0.44) respectively. Antiemetic use was similar in both groups (48.3 vs 55.7 % respectively, p = 0.42). CONCLUSIONS: There were no differences in the return of bowel function and other bowel symptoms postoperatively between the randomized groups. Lack of bowel preparation does not have an impact on the risk of painful defecation postoperatively. This information may be used to inform patients regarding expectations for bowel function after vaginal reconstructive surgery.

The effect of age on stress and urgency urinary incontinence outcomes in women undergoing primary midurethral sling.

INTRODUCTION AND HYPOTHESIS: The primary aim was to characterize stress urinary incontinence (SUI) symptom distress and impact after a midurethral sling (MUS) in women ≥70 compared to women <70 years of age. METHODS: A retrospective cohort study of women undergoing a primary MUS was conducted. The primary outcome was SUI symptoms defined as either "moderately" or "quite a bit" responses to ≥1 of the two SUI questions of the Pelvic Floor Distress Inventory-20 (PFDI-20). Urgency urinary incontinence (UUI) was defined as either moderately or quite a bit responses to the UUI question of the PFDI-20. The Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Satisfaction Questionnaire (PSQ), and Patient Global Impression of Improvement (PGI-I) questionnaires were also administered. RESULTS: The mean age of patients ≥70 years (n = 160) was 75.4 ± 4.5 and <70 years (n = 536) was 56.2 ± 9.4. Multivariable analysis revealed no difference in SUI failure rates in older compared to younger cohorts, adjusted odds ratio (OR) 1.7, 95 % confidence interval (CI) 0.9-3.1. Women <70 demonstrated greater improvement in urinary incontinence (UI) symptom impact [-20.4 (33.0) vs -12.2 (30.7), p = 0.01] and women ≥70 had greater persistent UUI symptoms (31.5 vs 23.3 %, p = 0.04); there was no difference between cohorts in resolution of UUI (29.6 vs 34.2 %, p = 0.34). Younger women reported a greater impression of improvement compared to older women (67.7 vs 56.6 %, p = 0.01, respectively). CONCLUSIONS: Older and younger women have similar SUI outcomes after MUS; however, older women have more persistent UUI and a worse impression of improvement of their urinary tract condition.

The role of vaginal mesh procedures in pelvic organ prolapse surgery in view of complication risk.

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.

The effect of obesity on fecal incontinence symptom distress, quality of life, and diagnostic testing measures in women.

INTRODUCTION AND HYPOTHESIS: Weight-loss has been demonstrated to result in an improvement in fecal incontinence (FI) severity; however, there is a paucity of data addressing the differential impact of FI on the quality of life (QOL) and results of diagnostic testing across BMI categories. We wished to evaluate symptom distress, QOL, and diagnostic testing parameters among normal, overweight, and obese women with fecal incontinence. METHODS: Women undergoing evaluation for FI between 2003 and 2012 were identified. Participants completed validated, symptom-specific distress, impact, and general QOL measures including the Modified Manchester Questionnaire (MMHQ), which includes the Fecal Incontinence Severity Index (FISI), and the mental and physical component summary scores, MCS and PCS, respectively, of the Short Form-12. Anorectal manometry measures were also included. Multivariate regression analyses were performed. RESULTS: Participants included 407 women with a mean age ± SD of 56 ± 13. Multivariate analyses revealed no differences in symptom-specific distress and impact as measured by MMHQ, MCS, and PCS across BMI groups; however, obese women had increased resting and squeeze pressures compared with normal and overweight BMI women (p < 0.0001 and p < 0.0001; p = 0.007 and p = 0.004 respectively). CONCLUSIONS: Obese women with FI did not have more general impact and symptom-specific distress and impact on quality of life compared with normal and overweight women. Obese women with FI had higher baseline anal resting and squeeze pressures suggesting a lower threshold to leakage with pressure increases.

Indications, contraindications, and complications of mesh in surgical treatment of pelvic organ prolapse.

Women are seeking care for pelvic organ prolapse in increasing numbers and a significant proportion of them will undergo a second repair for recurrence. This has initiated interest by both surgeons and industry to utilize and design prosthetic mesh materials to help augment longevity of prolapse repairs. Unfortunately, the introduction of transvaginal synthetic mesh kits for use in women was done without the benefit of level 1 data to determine its utility compared with native tissue repair. This report summarizes the potential benefit/risks of transvaginal synthetic mesh use for pelvic organ prolapse and recommendations regarding its continued use.

Serum concentrations and clinical effects of atorvastatin in patients taking grapefruit juice daily.

AIM: To determine whether customary exposure to grapefruit juice (GFJ) alters serum concentrations, effectiveness, and potential adverse effects of atorvastatin in patients requiring the medication. METHODS: Patients receiving extended treatment with atorvastatin (10, 20 or 40 mg day(-1)) at a stable dose received 300 ml day(-1) of 100% GFJ for a period of 90 days. One cohort of patients (arm A, n= 60) continued on their current dose of atorvastatin; the second cohort (arm B, n= 70) reduced the daily dose by 50%. Serum atorvastatin, lipid profile, liver functions, and creatine phosphokinase (CPK) were measured at baseline and at 30, 60, and 90 days after starting GFJ. RESULTS: In Arm A patients, co-ingestion of GFJ significantly elevated serum atorvastatin by 19% to 26% compared with baseline. Changes in lipid profile relative to baseline were negligible. There were no adverse effects on liver function tests or CPK. In arm B patients, serum atorvastatin declined by 12% to 25% compared to baseline, with a small but significant unfavourable effect in serum lipid profile. There were no adverse effects on liver function tests or CPK. CONCLUSION: In patients on extended stable atorvastatin treatment, addition of daily GFJ in typical quantities slightly elevates serum atorvastatin concentrations, but has no meaningful effect on the serum lipid profile, and causes no detectable adverse liver or muscle effects. Reduction of atorvastatin dosage when moderate amounts of GFJ are co-ingested does not appear to be necessary.