Charles W. Nager

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.)

Parity, Mode of Delivery, and Pelvic Floor Disorders

OBJECTIVE: This study aimed to assess the associations between parity, mode of delivery, and pelvic floor disorders. METHODS: The prevalence of pelvic organ prolapse, stress urinary incontinence, overactive bladder, and anal incontinence was assessed in a random sample of women aged 25–84 years by using the validated Epidemiology of Prolapse and Incontinence Questionnaire. Women were categorized as nulliparous, vaginally parous, or only delivered by cesarean. Adjusted odds ratios and 95% confidence intervals (CIs) for each disorder were calculated with logistic regression, controlling for age, body mass index, and parity. RESULTS: In the 4,458 respondents the prevalence of each disorder was as follows: 7% prolapse, 15% stress urinary incontinence, 13% overactive bladder, 25% anal incontinence, and 37% for any one or more pelvic floor disorders. There were no significant differences in the prevalence of disorders between the cesarean delivery and nulliparous groups. The adjusted odds of each disorder increased with vaginal parity compared with cesarean delivery: prolapse = 1.82 (95% CI 1.04–3.19), stress urinary incontinence = 1.81 (95% CI 1.25–2.61), overactive bladder = 1.53 (95% CI 1.02–2.29), anal incontinence = 1.72 (95% CI 1.27–2.35), and any one or more pelvic floor disorders = 1.85 (95% CI 1.42–2.41). Number-needed-to-treat analysis revealed that 7 women would have to deliver only by cesarean delivery to prevent one woman from having a pelvic floor disorder. CONCLUSION: The risk of pelvic floor disorders is independently associated with vaginal delivery but not with parity alone. Cesarean delivery has a protective effect, similar to nulliparity, on the development of pelvic floor disorders when compared with vaginal delivery. LEVEL OF EVIDENCE: II-2

Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women.

OBJECTIVE: To assess the effect of age on prevalence of pelvic floor disorders and report the co-occurrence of these conditions in community-dwelling women. METHODS: Stress urinary incontinence (SUI), overactive bladder (OAB), pelvic organ prolapse (POP), and anal incontinence were assessed using a validated questionnaire among 25- to 84-year-old women. Women screened positive for each disorder based on reported symptoms and their degree of bother. Covariates were assessed through self-report. Prevalence of each disorder was compared across four 15-year age groups using &khgr;2 tests. Multiple logistic regression was used to adjust for confounders. RESULTS: Among 4,103 women (mean age 56.5±15.8 years), the prevalence of SUI was 15%, OAB 13%, POP 6%, anal incontinence 25%, and 37% for any one or more disorder. Although the unadjusted prevalence of SUI, OAB, and anal incontinence increased with increasing age category, age was no longer significantly associated with the prevalence of any condition in most categories after adjustment for confounders, including obesity, birth history, menopause, and hormones. Co-occurrence of the disorders was high; roughly 80% of women with SUI or OAB, 69% with POP, and 48% with anal incontinence reported at least one other disorder. CONCLUSION: Although the prevalence of pelvic floor disorders in a community-dwelling population is high, age was not a significant contributor after adjustment for confounders. The high co-occurrence of pelvic floor disorders suggests that physicians seeing women seeking care for one condition should inquire about symptoms of other disorders. LEVEL OF EVIDENCE: II

A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair

BACKGROUND Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Womens Health; OPUS ClinicalTrials.gov number, NCT00460434.).

Risk factors for mesh/suture erosion following sacral colpopexy

OBJECTIVE The purpose of this study was to identify risks for mesh/suture erosions following abdominal sacral colpopexy (ASC). STUDY DESIGN We analyzed demographic, perioperative variables, and erosion status in 322 participants in the Colpopexy and Urinary Reduction Efforts study 2 years after sacral colpopexy. RESULTS The predominant graft used was synthetic mesh: woven polyester (Mersilene; Ethicon, Inc, Somerville, NJ) (42%) or polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 [19%] vs non-ePTFE 16/301 [5%]; odds ratio [OR], 4.2), concurrent hysterectomy (OR, 4.9), and current smoking (OR, 5.2). Of those with mesh erosion, most affected women (13/17) underwent at least 1 surgery for partial or total mesh removal. Two were completely resolved, 6 had persistent problems, and 5 were lost to follow-up. No resolution was documented in the 4 women who elected observation. CONCLUSION Expanded PTFE mesh should not be used for sacral colpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.

Urodynamic Measures Do Not Predict Stress Continence Outcomes After Surgery for Stress Urinary Incontinence in Selected Women

PURPOSE We determined the prognostic value of preoperative urodynamic results in patients with stress urinary incontinence. MATERIALS AND METHODS In a 9-center surgical trial, women with stress urinary incontinence were randomized to a Burch or pubovaginal sling procedure. Women were eligible for the study if they had predominant stress urinary incontinence symptoms, a positive cough stress test, a bladder capacity more than 200 ml and urethral hypermobility. Preoperative free uroflowmetry, filling cystometry and pressure flow studies were performed in all. Overall treatment success required a negative pad test, no urinary incontinence on a 3-day diary, a negative stress test, no self-reported stress urinary incontinence symptoms and no re-treatment for stress urinary incontinence. Stress specific success required all of the last 3 criteria. We examined urodynamic measures, and whether the presence of urodynamic stress incontinence, the presence of detrusor overactivity and Valsalva leak point pressure would predict surgical success. RESULTS Subjects with urodynamic stress incontinence had a 2-fold greater odds of overall success when compared with the No urodynamic stress incontinence group, but this trend did not quite reach statistical significance (OR 2.26; 95% C.I. 0.99, 5.17). Odds of stress specific success did not differ by urodynamic stress incontinence status. Subjects with detrusor overactivity did not have significantly worse success rates. Stratifying by treatment group, there was no difference in mean Valsalva leak point pressure values between surgical successes and failures. CONCLUSIONS We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence. The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence. The impact of urodynamic studies on surgical outcomes needs further investigation.

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy.

Introduction and hypothesisThe purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy.MethodsThis is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion.ResultsOf 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88–17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model.ConclusionBased on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated.

Pelvic Floor Disorders, Diabetes, and Obesity in Women: Findings from the Kaiser Permanente Continence Associated Risk Epidemiology Study

OBJECTIVE—We examined associations between obesity and diabetes and female pelvic floor disorders (PFDs), stress urinary incontinence (SUI), overactive bladder (OAB), and anal incontinence (AI) in community-dwelling women. RESEARCH DESIGN AND METHODS—Women were screened for PFD using a validated mailed survey. Diabetes status, glycemic control, and diabetes treatment were extracted from clinical databases, while other risk factors for PFDs were obtained through self-report. Women were categorized hierarchically as nonobese/nondiabetic (reference), nonobese/diabetic, obese/nondiabetic, and obese/diabetic. RESULTS—Of 3,962 women, 393 (10%) had diabetes. In unadjusted analyses, women with diabetes and women who were obese had greater odds of having PFDs. Among women with diabetes, being obese was associated with SUI and OAB. After adjusting for confounders, we found that obese/diabetic women were at the highest likelihood of having SUI (odds ratio 3.67 [95% CI 2.48–5.43]) and AI (2.09 [1.48–2.97]). The odds of having OAB among obese women was the same for obese/diabetic women (2.97 [2.08–4.36]) and obese/nondiabetic women (2.93 [2.33–3.68]). Nonobese/diabetic women had higher odds of SUI (1.90 [1.15–3.11]) but did not differ significantly in their OAB (1.45 [0.88–2.38]) and AI (1.33 [0.89–2.00]) prevalence from nonobese/nondiabetic women. CONCLUSIONS—Given the impaired quality of life experienced by women with PFDs, health care providers should counsel women that obesity and diabetes may be independent modifiable risk factors for PFDs.

Predictive value of prolapse symptoms: a large database study

We sought to describe the relationship between patient symptoms and pelvic organ prolapse (POP) and report the sensitivity, specificity, and positive and negative predictive value of these POP symptoms. Two urologists and four urogynecologists developed a standardized pelvic floor questionnaire based on face validation for use at three female pelvic floor disorder clinics. Specific questions related to prolapse included questions on urinary splinting, digital assistance for defecation, and a bulge per vagina. Prolapse was assessed with the standardized Pelvic Organ Prolapse Quantitative (POP-Q) terminology. The analysis included 1912 women. Urinary splinting was uncommon (<10%) when Ba <0, but ranged between 23 and 36% for stage III and IV Ba prolapse. Digital assistance was equally common in stage II Bp prolapse (21–38%) and stage III-IV Bp prolapse (26–29%). Only 6–11% of women with stage 0 or I POP reported symptoms of bulge, but with stage II it increased to 77%. Urinary splinting is 97% specific for anterior prolapse. The report of a bulge has an 81% positive predictive value and a 76% negative predictive value. Very few patients without anterior prolapse will report urinary splinting. Digital assistance for fecal evacuation is no more common with massive posterior prolapse than with moderate posterior prolapse. Patient report of a bulge is a valuable screening tool for POP and should prompt a careful exam.

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.