Michael E. Albo

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.)

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study.

OBJECTIVE To describe surgical complications in 597 women over a 24-month period after randomization to retropubic or transobturator midurethral slings. STUDY DESIGN During the Trial of Midurethral Slings study, the Data Safety Monitoring Board regularly reviewed summary reports of all adverse events using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinicodemographic factors and surgical complications. RESULTS A total of 383 adverse events were observed among 253 of the 597 women (42%). Seventy-five adverse events (20%) were classified as serious (serious adverse events); occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs 20 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups. CONCLUSION Adverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae.

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.

Intravesical Potassium Sensitivity in Patients With Prostatitis

PURPOSE Prostatitis and interstitial cystitis encompass similar symptoms and may be manifestations of a single pathophysiological process in the lower urinary tract. Most patients with interstitial cystitis have urinary epithelial dysfunction, as indicated by a positive intravesical potassium sensitivity test. We used the potassium sensitivity test for the presence of epithelial dysfunction in men with diagnosed prostatitis. MATERIALS AND METHODS We administered the potassium sensitivity test in men who presented with the signs and symptoms of prostatitis (urgency/frequency and/or pelvic pain) after being diagnosed with prostatitis and receiving at least 1 course of antibiotic treatment administered by a urologist other than one of us. We also surveyed the patients for urinary symptoms and pain locations using 2 self-evaluation questionnaires. RESULTS A total of 44 patients with prostatitis completed the questionnaires and underwent the potassium sensitivity test. Of the 44 men 37 (84%) had positive potassium sensitivity test results, 89% reported urinary urgency/frequency and 82% reported pain. Pain locations included the perineum, lower abdomen, lower back, penis, testes, scrotum and rectum as well as dysuria and post-void pain. Pain with sexual intercourse was reported by 75% of the patients with prostatitis. CONCLUSIONS The rate of positive potassium sensitivity test results in patients with prostatitis is almost identical to that reported in those with interstitial cystitis (84% and 79%, respectively), suggesting that prostatitis and interstitial cystitis may be a continuum of lower urinary epithelial dysfunction. Similar to patients with interstitial cystitis, most patients with prostatitis experience pain during sexual intercourse and perceive pain at locations throughout the pelvis. We suggest reclassifying the prostatitis-interstitial cystitis disease process as lower urinary dysfunctional epithelium.

Spinal Cord Injury and Sexuality in Married or Partnered Men: Activities, Function, Needs, and Predictors of Sexual Adjustment

The sexual behaviors, functioning, needs, and sexual satisfaction levels of men with spinal cord injuries (SCI) were studied. A sample of 50 men with SCI (median age = 50; median age at injury = 25.0), either married or in a committed relationship, responded to an anonymous survey of a large southern California regional spinal injury rehabilitation center. Multiple regression analyses indicated that perceived partner satisfaction, relationship quality, and sexual desire were significant predictors of sexual satisfaction and behavior. Erectile function, level of genital sensation, and orgasmic capacity all varied widely in the sample, as well. However, none of these variables were significantly related to sexual satisfaction. A varied sexual repertoire was independently related to sexual satisfaction and behavior, but did not offer additional predictive power. Results suggest that for married or partnered men with SCI, relationship factors including partner satisfaction and relationship quality are significantly and positively related to sexual satisfaction. Married or partnered men with SCI who report low relationship satisfaction, have difficulty satisfying their partner, and/or report low sexual desire may benefit from assessments and interventions that address these issues.

Predictors of Treatment Failure 24 Months After Surgery For Stress Urinary Incontinence

PURPOSE We identified baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence. MATERIALS AND METHODS Data were obtained from 655 women randomized to Burch colposuspension or autologous rectus sling. Of those, 543 (83%) had stress failure status assessed at 24 months (269 Burch, 274 sling). Stress failure (261) was defined as self-report of stress urinary incontinence by the Medical, Epidemiological, and Social Aspects of Aging questionnaire, positive stress test or re-treatment for stress urinary incontinence. Nonstress failure (66) was defined as positive 24-hour pad test (more than 15 ml) or any incontinent episodes by 3-day voiding diary with none of the 3 criteria for stress failure. Subjects not meeting any failure criteria were considered a treatment success (185). Adjusting for surgical treatment group and clinical site, logistic regression models were developed to predict the probability of treatment failure. RESULTS Severity of urge incontinence symptoms (p = 0.041), prolapse stage (p = 0.013), and being postmenopausal without hormone therapy (p = 0.023) were significant predictors for stress failure. Odds of nonstress failure quadrupled for every 10-point increase in Medical, Epidemiological, and Social Aspects of Aging questionnaire urge score (OR 3.93 CI 1.45, 10.65) and decreased more than 2 times for every 10-point increase in stress score (OR 0.36, CI 0.16, 0.84). The associations of risk factors and failure remained similar regardless of surgical group. CONCLUSIONS Two years after surgery, risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on hormone replacement therapy. Higher urge scores predicted failure by nonstress specific outcomes.

Treatment success of retropubic and transobturator mid urethral slings at 24 months

PURPOSE Longer term comparative efficacy information regarding transobturator and retropubic mid urethral slings is needed. We report 24-month continence rates, complications and symptom outcomes from a randomized equivalence trial. MATERIALS AND METHODS Primary outcomes were objective (negative stress test, negative pad test and no re-treatment for stress urinary incontinence) and subjective (no self-report of stress urinary incontinence symptoms, no leakage episodes on 3-day bladder diary and no re-treatment for stress urinary incontinence) success at 24 months. The predetermined equivalence margin was ± 12%. RESULTS Of 597 randomized participants 516 (86.4%) were assessed. Objective success rates for retropubic and transobturator mid urethral slings were 77.3% and 72.3%, respectively (95% CI for difference of 5.1% was -2.0, 12.1), and subjective success rates were 55.7% and 48.3%, respectively (CI for difference of 7.4% was -0.7, 15.5). Neither objective nor subjective success rates met the prespecified criteria for equivalence. Patient satisfaction (retropubic 86.3% vs transobturator 88.1%, p = 0.58), frequency of de novo urgency incontinence (retropubic 0% vs transobturator 0.3%, p = 0.99) and occurrence of mesh exposure (retropubic 4.4% vs transobturator 2.7%, p = 0.26) were not significantly different. The retropubic mid urethral sling group had higher rates of voiding dysfunction requiring surgery (3.0% vs 0%, p = 0.002) and urinary tract infections (17.1% vs 10.7%, p = 0.025), whereas the transobturator group had more neurological symptoms (9.7% vs 5.4%, p = 0.045). CONCLUSIONS Objective success rates met the criteria for equivalence at 12 months but no longer met these criteria at 24 months. Subjective success rates remained inconclusive for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved. Continued surveillance is important in women undergoing mid urethral sling surgery.

5-Year Longitudinal Followup after Retropubic and Transobturator Mid Urethral Slings

PURPOSE Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. MATERIALS AND METHODS Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. RESULTS Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4). CONCLUSIONS Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.

Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline

Purpose: Stress urinary incontinence is a common problem experienced by many women that can have a significant negative impact on the quality of life of those who suffer from the condition and potentially those friends and family members whose lives and activities may also be limited. Materials and Methods: A comprehensive search of the literature was performed by ECRI Institute. This search included articles published between January 2005 and December 2015 with an updated abstract search conducted through September 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. Results: The AUA (American Urological Association) and SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction) have formulated an evidence‐based guideline focused on the surgical treatment of female stress urinary incontinence in both index and non‐index patients. Conclusions: The surgical options for the treatment of stress urinary incontinence continue to evolve; as such, this guideline and the associated algorithm aim to outline the currently available treatment techniques as well as the data associated with each treatment. Indeed, the Panel recognizes that this guideline will require continued literature review and updating as further knowledge regarding current and future options continues to grow.

DIAGNOSIS OF STRESS URINARY INCONTINENCE

This article represents an overview of the evaluation and diagnosis of stress urinary incontinence. Lower urinary tract anatomy in women is reviewed with particular attention to the salient features contributing to stress incontinence. Also discussed is the relevance of the distinction between anatomic incontinence and intrinsic sphincter deficiency in the classification of stress urinary incontinence. Various diagnostic techniques are described with emphasis on the importance of urodynamic evaluation in complex cases.