A systematic review of clinical studies of electrical stimulation for treatment of lower urinary tract dysfunction.

INTRODUCTION AND HYPOTHESIS: The aim of this manuscript was to provide a systematic literature review of clinical trial evidence for a range of electrical stimulation therapies in the treatment of lower urinary tract symptoms (LUTS). METHODS: The databases MEDLINE, BIOSIS Previews, Inside Conferences, and EMBASE were searched. Original clinical studies with greater than 15 subjects were included. RESULTS: Seventy-three studies were included, representing implanted sacral nerve stimulation (SNS), percutaneous posterior tibial nerve stimulation (PTNS), and transcutaneous electrical stimulation (TENS) therapy modalities. CONCLUSIONS: Median mean reductions in incontinence episodes and voiding frequency were similar for implanted SNS and PTNS. However, long-term follow-up data to validate the sustained benefit of PTNS are lacking. Despite a substantial body of research devoted to SNS validation, it is not possible to definitively define the appropriate role of this therapy owing largely to study design flaws that inhibited rigorous intention to treat analyses for the majority of these studies.

Duloxetine compared with placebo for the treatment of women with mixed urinary incontinence.

AIMS: Evaluate duloxetine in the treatment of women with mixed urinary incontinence (MUI). MATERIALS AND METHODS: 588 women, 19-85 years old with >or=4 incontinence episodes/week were randomly assigned to duloxetine 80 mg/day (N = 300) or placebo (N = 288). Patients were classified into three symptom subgroups: stress or urge predominant MUI (SPMUI or UPMUI) or balanced MUI (BMUI) based on their responses to the validated Stress/Urge Incontinence Questionnaire. Half the population was randomly assigned to have urodynamics; SPMUI, UPMUI, and BMUI condition diagnoses were based on signs, symptoms, and urodynamic observations. The primary outcome measure was the change in incontinence episode frequency (IEF). Secondary outcome measures included the Incontinence Quality of Life (I-QOL) scores, the ICI Quality of Life (ICIQ-SF) score, and the Patient Global Impression of Improvement (PGI-I) rating. RESULTS: At baseline, women with SPMUI averaged 15.9 IEF/week (61% stress), those with UPMUI averaged 13.2 (70% urge), and those with BMUI averaged 16.5 (52% urge). Overall IEF decreases were significantly greater with duloxetine than placebo (median percent reduction 60% vs. 47%, P < 0.001); both UUI and SUI episodes were significantly decreased with duloxetine (median SUI IEF reduction 59% vs. 43%, P = 0.001; UUI IEF reduction 58% vs. 40%, P < 0.001). Duloxetine IEF decreases were significantly greater for patients with SPMUI conditions and symptoms and for those with UPMUI conditions but not symptoms. Significant benefits were also demonstrated with duloxetine for improvements in I-QOL total score (11.5 points vs. 8.1 points, P = 0.002), all three I-QOL subscale scores, and for the ICIQ-SF score (-2.6 vs. -1.7, P = 0.002) as well as for PGI-I ratings (much/very much better 44.2% vs. 27.3%, P = 0.001). CONCLUSION: Duloxetine demonstrated significant efficacy in this population of women with MUI.

Collagen metabolism in the uterosacral ligaments and vaginal skin of women with uterine prolapse.

OBJECTIVE: To compare tissue markers of collagen metabolism in the uterosacral ligaments with those in vaginal tissue in women with uterine prolapse. DESIGN: Prospective observational experimental study. SETTING: A tertiary urogynaecology unit. POPULATION: Women referred for hysterectomy for prolapse or benign gynaecological disease. METHODS: Matrix metalloproteinase (MMP)-2 and -9 expression, tissue inhibitors of metalloproteinase (TIMP)-2 expression and hydroxyproline content were measured in the uterosacral ligaments and vaginal tissue from 14 women with prolapse compared with 14 controls. MAIN OUTCOME MEASURES: Levels of MMP, TIMP and hydroxyproline in the uterosacral ligaments and vaginal tissue of women with prolapse and controls. RESULTS: Fourteen women with prolapse and 14 women without prolapse (controls) were included. A significant increase in pro MMP-2 expression was seen in vaginal tissue from women with prolapse (P < 0.05) but not activated MMP-2, MMP-9 and TIMP-2. For uterosacral ligaments, the differences were not statistically significant. No significant difference in hydroxyproline content was found between control and prolapse in either tissue. Significant correlations exist in expression of pro-MMP-2, activated MMP-2, MMP-9 and TIMP-2 in vaginal tissue with that in uterosacral ligaments. CONCLUSIONS: Correlations existed between markers of collagen metabolism in the vaginal and uterosacral tissues. This suggests vaginal tissue reflects the endopelvic fascia. The changes which are more pronounced in vaginal tissue may be as a result of prolapse rather than cause.

Validation of a two-item quantitative questionnaire for the triage of women with urinary incontinence.

OBJECTIVE: To evaluate the reproducibility, construct validity, and preferences for the 2-item Stress/Urge Incontinence Questionnaire. METHODS: The questionnaire asks a patient to recall the number of stress urinary incontinence and urge urinary incontinence episodes she experienced during the preceding week. The 4-week prospective study included 3 office visits and enrolled women with stress, urge, or mixed urinary incontinence symptoms. The test-retest reproducibility was assessed after 3 days, and the construct validity of the questionnaire was evaluated against a diary and other measures of incontinence severity and effect. The bother associated with completing (patients) or analyzing (physicians) the diary was assessed. Both groups also reported their time requirements and preferences for the questionnaire or diary. RESULTS: Reproducibility for the classification of symptoms was moderately strong (kappa = .536). Test-retest agreement was good (64-80%) for all but balanced mixed incontinence (38%). Intraclass correlations revealed good reproducibility for the number of stress (.694), urge (.703), and total (.726) incontinence episodes. Significant (P < .01) correlations with other measures of incontinence established construct validity. Patients and physicians reported it took less time to complete the questionnaire than the diary, but the majority said the completion or analysis of the diary was of little or no bother and preferred the diary. CONCLUSION: The Stress/Urge Incontinence Questionnaire is a valid tool that can be used in clinical practice to differentiate between symptoms of stress and urge urinary incontinence to make an initial diagnosis, especially in primary care where incontinence is not a focus of the practice.