R. Edward Varner

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.)

A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes

Abstract Objective To compare surgical complications and clinical outcomes after total versus supracervical abdominal hysterectomy for control of abnormal uterine bleeding, symptomatic uterine leiomyomata, or both. Methods We conducted a randomized intervention trial in four US clinical centers among 135 patients who had abdominal hysterectomy for symptomatic uterine leiomyomata, abnormal uterine bleeding refractory to hormonal treatment, or both. Patients were randomly assigned to receive a total or supracervical hysterectomy performed using the surgeons customary technique. Using an intention-to-treat approach, we compared surgical complications and clinical outcomes for 2 years after randomization. Results Sixty-eight participants were assigned to supracervical hysterectomy (SCH) and 67 to total abdominal hysterectomy (TAH). Hysterectomy by either technique led to statistically significant reductions in most symptoms, including pelvic pain or pressure, back pain, urinary incontinence, and voiding dysfunction. Patients randomly assigned to (SCH) tended to have more hospital readmissions than those randomized to TAH, but this difference was not statistically significant. There were no statistically significant differences in the rate of complications, degree of symptom improvement, or activity limitation. Participants weighing more than 100 kg at study entry were twice as likely to be readmitted to the hospital during the 2-year follow-up period (relative risk [RR] 2.18, 95% confidence interval [CI] 1.06, 4.48, P = .034). Conclusion We found no statistically significant differences between (SCH) and TAH in surgical complications and clinical outcomes during 2 years of follow-up.

Sexual functioning after total compared with supracervical hysterectomy: a randomized trial.

OBJECTIVE: To compare sexual functioning and health-related quality-of-life outcomes of total abdominal hysterectomy (TAH) and supracervical hysterectomy (SCH) among women with symptomatic uterine leiomyomata or abnormal uterine bleeding refractory to hormonal management. METHODS: We randomly assigned 135 women scheduled to undergo abdominal hysterectomy in 4 U.S. clinical centers to either a total or supracervical procedure. The primary outcome was sexual functioning at 2 years, as assessed by the Medical Outcomes Study Sexual Problems Scale. Secondary outcomes included specific aspects of sexual functioning and health-related quality-of-life at 6 months and 2 years. RESULTS: Sexual problems improved dramatically in both randomized groups during the first 6 months and plateaued by 1 year. Health-related quality-of-life scores also improved in both groups. At 2 years, both groups reported few problems with sexual functioning (mean score on the Sexual Problems Scale for SCH group 82, TAH group 80, on a 0-to-100 scale with 100 indicating an absence of problems; difference = +2, 95% confidence interval –8 to + 11), and there were no significant differences between groups. CONCLUSION: Supracervical and total abdominal hysterectomy result in similar sexual functioning and health-related quality of life during 2 years of follow-up. This information can help guide physicians as they discuss surgical options with their patients. LEVEL OF EVIDENCE: I

Urinary and anal incontinence in morbidly obese women considering weight loss surgery.

OBJECTIVE: To estimate prevalence and correlates of urinary and anal incontinence in morbidly obese women undergoing evaluation for laparoscopic weight loss surgery. METHODS: From October 2003 to February 2005, 180 women with body mass index (BMI) of 40 or greater underwent evaluation for laparoscopic weight loss surgery. Using an established Web site, questionnaires were completed to assess symptoms of urinary incontinence, including the Medical, Epidemiological, and Social Aspects of Aging Questionnaire (MESA). Anal incontinence was assessed by asking, “Do you have any uncontrolled anal leakage?” A number of clinical and demographic variables were examined as potential risk factors for urinary incontinence and anal incontinence. RESULTS: Mean age was 39.8 years (range 16–55). Body mass index ranged from 40 to 81 (mean 49.5). Prevalence of urinary incontinence was 66.9% and anal incontinence was 32.0% (45.6% loss of gas only, 21.1% liquid stool only, 24.6% gas and liquid stool only, 8.8% solid stool). In simple logistic regression, presence of urinary incontinence was associated with age (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.01–1.09), number of children (OR 1.54, 95% CI 1.15–2.07), anal incontinence (OR 6.34, 95% CI 2.52–15.93), arthritis (OR 6.04, 95% CI 1.76–20.78), and sleep apnea (OR 2.30, 95% CI 1.21–4.37). Multivariable logistic regression identified 3 factors independently associated with urinary incontinence: number of children (OR 1.55, 95% CI 1.12–2.12), arthritis (OR 5.46, 95% CI 1.51–19.73), and anal incontinence (OR 6.27, 95% CI 2.42–16.26). Presence of anal incontinence was associated only with the presence of urinary incontinence (OR 6.34, 95% CI 2.52–15.93). CONCLUSION: Prevalence of urinary and anal incontinence is high in this group of morbidly obese women as compared with the general population. Studies are needed to determine the effect of weight loss on urinary and anal incontinence symptoms in the morbidly obese woman. LEVEL OF EVIDENCE: III

A psychophysical study of discomfort produced by repeated filling of the urinary bladder.

&NA; Psychophysical studies were performed in 10 healthy, female volunteers using urinary bladder distension (UBD) as a visceral stimulus. Stimulus methodology was similar to that used clinically for obtaining cystometrograms with a fixed‐rate (100 cc/min normal saline) filling of the urinary bladder, occasional pauses and simultaneous measure of bladder pressure using a catheter–transducer assembly. During bladder filling, subjects were asked to report sensations by verbal report and by using an electronic, hand‐held, visual‐analog‐scale device. Sensations evoked by UBD were generally localized to the suprapubic region. UBD produced cardiovascular responses which increased with repeated trials. Sensation intensity increased with repeated UBDs as indicated by global pain ratings. Intravesical pressure and volume correlated with sensation intensity. The volume of distending fluid needed to produce a report of discomfort was highly variable from trial to trial and did not change significantly with repeated UBDs. The intravesical pressure which produced a report of discomfort was less variable and significantly decreased with repeated UBDs. The change in intravesical pressure and volume needed to produce discomfort was inversely correlated with initial intravesical pressure measures. Similar to findings in other organ systems, these findings demonstrate that repeated presentations of a visceral stimulus may lead to an increase in physiological and perceptual responses to pain.

Predictors of outcome in the behavioral treatment of urinary incontinence in women.

OBJECTIVE To identify predictors of outcome of a multi-component behavioral training program for urge and stress incontinence in women. METHODS This report is a secondary analysis of data from three prospective, randomized, clinical trials testing behavioral interventions for urinary incontinence. Participants were a volunteer sample of 258 ambulatory, nondemented, community-dwelling women, aged 40–92 years, with stress, urge, or mixed urinary incontinence. Participants received 8 weeks (four visits) of multicomponent behavioral training in each study. The relationship between a number of variables and treatment success were explored by univariate and multivariable logistic regression analyses. RESULTS Successful treatment of predominantly urge incontinence (75% reduction of incontinent episodes as recorded on bladder diary) was associated with not wearing any form of protection for incontinence (P = .045; 95% confidence interval [CI] .282, .987). Achieving total continence (100% reduction) was associated with fewer incontinent episodes at baseline (P < .001; 95% CI .138, .557), previous surgery for incontinence (P = .021; 95% CI 1.169, 6.543), and lower education level (P = .022; 95% CI .175, .871). Successful treatment of predominantly stress incontinence (75% reduction) was related to not having previous evaluation or treatment for incontinence (P = .001; 95% CI .026, .415), and fewer incontinent episodes on baseline bladder diary (P = .026; 95% CI .210, .907). Outcomes were not associated with age, race, type of incontinence, or a number of other variables reflecting medical history, obstetric history, medications, pelvic examination, body mass index, urodynamic parameters, or psychological distress. CONCLUSION Aside from indicators of severity and previous treatment, there were few associations between baseline clinical variables and outcome of behavioral treatment.

Hysterectomy versus expanded medical treatment for abnormal uterine bleeding: clinical outcomes in the medicine or surgery trial.

OBJECTIVE: To compare clinical outcomes after randomization to hysterectomy versus medical treatment in patients with chronic abnormal uterine bleeding refractory to medroxyprogesterone acetate. METHODS: We randomly assigned 63 premenopausal women with abnormal uterine bleeding refractory to cyclic medroxyprogesterone acetate treatment to receive either a hysterectomy or expanded medical treatment. Within each randomized group, the specific treatment approach was determined by patient and provider preference. The primary analysis compared changes in clinical outcomes at 6 and 24 months by using an intention-to-treat approach. Secondary as-treated analyses after adjustment for baseline covariates compared participants randomly assigned to medical treatment who continued the medical approach with those who crossed over to hysterectomy. RESULTS: The intention-to-treat analyses at 6 months revealed greater symptom improvement in the hysterectomy group than in the medicine group for pelvic pain (P < .01), urinary urgency (P = .03), incomplete bladder emptying (P = .03), breast pain (P = .02), and cessation of vaginal bleeding (87% versus 11%, P < .001). Seventeen of 32 women assigned to medicine (53%) eventually crossed over and received a hysterectomy, and by 24 months the statistically significant differences by intention-to-treat were limited to greater improvement in hot flushes (P < .01) and cessation of vaginal bleeding (P < .01). Within-group analyses at year 2 showed statistically significant improvements from baseline on most symptoms for women who had a hysterectomy, whether through randomization or crossover. Women remaining on medical treatments had statistically significant improvements in pelvic pain, pelvic/bladder pressure, and stress incontinence. In a nonrandomized comparison with women who remained on medical treatments through year 2, those crossing over to hysterectomy experienced greater improvements in bleeding (P < .01), pelvic pain (P < .01), low back pain (P = .02), breast pain (P = .01), urinary frequency (P = .01), and urgency (P = .02). However, they also experienced more days off from work or usual activities (P < .01) and more days spent in bed (P < .01) than those who remained on medicine. CONCLUSION: For patients with abnormal uterine bleeding refractory to medroxyprogesterone acetate, hysterectomy is superior to expanded efforts with oral medications for alleviating clinical symptoms but may lead to more days of restricted activity. LEVEL OF EVIDENCE: I

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

Background The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. Purpose To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. Methods The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. Results The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Limitations Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Conclusion Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information. Clinical Trials 2009; 6: 162—171. http://ctj.sagepub.com

Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial.

Background Non-surgical treatment for stress urinary incontinence (SUI) is recommended as first-line therapy, yet few prospective studies and no randomized trials compare the most common non-surgical treatments for SUI. Purpose To present the design and methodology of the ambulatory treatments for leakage associated with stress (ATLAS) trial, a randomized clinical trial comparing three interventions for predominant SUI in women: intravaginal continence pessary; behavioral therapy (including pelvic floor muscle training and exercise and bladder control strategies); and a combination of the two treatments. Methods Treatment outcome measures, collected at 12 weeks and six and 12 months post randomization, include the Patient Global Impression of Improvement (PGI-I), the Stress Incontinence Scale of the Pelvic Floor Distress Inventory (PFDI), seven-day bladder diaries, Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12), Patient Satisfaction Questionnaire (PSQ) and the Medical Outcomes Study Short Form Health Survey (SF-36). Limitations The study design reduces most common biases, but some degree of selection bias may remain. Conclusion This trial will provide useful information to help counsel women with stress and mixed incontinence about the relative efficacy and satisfaction with pessary, behavioral therapy and both treatments combined.

Retropubic long-needle suspension procedures for stress urinary incontinence

A brief review of the Pereyra and the Stamey procedures and their modifications, including success rates and potential problems, is presented. A new modified technique is described that has potential advantages of ease, rapidity, less dissection, and less blood loss than may be seen with the modified Pereyra procedure and less chance of foreign body reaction than may be seen with the Stamey procedure. Twenty patients with significant stress urinary incontinence (14 with concurrent severe pelvic relaxation) underwent the procedure with an 80% cure plus 5% significant improvement rate noted 12 to 39 months after operation. All failures occurred in patients who were obese and involved apparent suture pull-through. Complications were minimal. Suggested causes for failures are discussed.