BACKGROUND: To evaluate the effectiveness of intravaginal electrical stimulation (ES) of the pelvic floor for urinary incontinence in elderly women, and to determine whether ES of the pelvic floor is a preferable treatment for urinary incontinence in elderly women. METHODS:Postmenopausal women (age 65 years or older) were enrolled in a randomized clinical trial and underwent every-other-day ES of the pelvic floor, or a daily Kegel exercise (KE) program. Objective outcome variables were: (1) Urinary leakage (during a standardized PAD test), (2) pelvic muscle strength (measured by a perineometer), and (3) detrusor instability (on ambulant urodynamic registration). Subjective outcome variables were women's subjective assessment of change in urinary symptoms based on the PRAFAB score. Twenty-four women treated with ES and 11 women treated withKegel exercises completed the 8-week study program. The Chi-square test was used for statistical analysis. RESULTS: No significant improvement in objective outcome variables was observed in the population treated with ES compared with the population treated with KE (with 29.2% vs. 36.4% of the women showing objective improvement in measured urinary leakage). Neither was subjective improvement significant, with 29.2% vs. 27.3% of the women reporting improvement in the amount of urinary leakage. CONCLUSIONS: Although the number of enrolled women was very small this study shows that: 1. Treating elderly women with vaginal ES of the pelvic floor has a high physical and emotional cost for the individual. 2. The effectiveness of ES of the pelvic floor in urinary incontinent elderly women is low. 3. There is no great discrepancy between objective amelioration (PAD test) and subjective amelioration (PRAFAB score/quantity of urinary leakage), if the objective improvement is adequately defined. 4. It is not reasonable to advise elderly women with urinary incontinence to undertake this treatment procedure. The effectiveness of treatment does not compensate for the long-lasting and intense treatment protocol. 5. We terminated this study because of the negative outcome with ES.
RCT Entities:
BACKGROUND: To evaluate the effectiveness of intravaginal electrical stimulation (ES) of the pelvic floor for urinary incontinence in elderly women, and to determine whether ES of the pelvic floor is a preferable treatment for urinary incontinence in elderly women. METHODS: Postmenopausal women (age 65 years or older) were enrolled in a randomized clinical trial and underwent every-other-day ES of the pelvic floor, or a daily Kegel exercise (KE) program. Objective outcome variables were: (1) Urinary leakage (during a standardized PAD test), (2) pelvic muscle strength (measured by a perineometer), and (3) detrusor instability (on ambulant urodynamic registration). Subjective outcome variables were women's subjective assessment of change in urinary symptoms based on the PRAFAB score. Twenty-four women treated with ES and 11 women treated with Kegel exercises completed the 8-week study program. The Chi-square test was used for statistical analysis. RESULTS: No significant improvement in objective outcome variables was observed in the population treated with ES compared with the population treated with KE (with 29.2% vs. 36.4% of the women showing objective improvement in measured urinary leakage). Neither was subjective improvement significant, with 29.2% vs. 27.3% of the women reporting improvement in the amount of urinary leakage. CONCLUSIONS: Although the number of enrolled women was very small this study shows that: 1. Treating elderly women with vaginal ES of the pelvic floor has a high physical and emotional cost for the individual. 2. The effectiveness of ES of the pelvic floor in urinary incontinent elderly women is low. 3. There is no great discrepancy between objective amelioration (PAD test) and subjective amelioration (PRAFAB score/quantity of urinary leakage), if the objective improvement is adequately defined. 4. It is not reasonable to advise elderly women with urinary incontinence to undertake this treatment procedure. The effectiveness of treatment does not compensate for the long-lasting and intense treatment protocol. 5. We terminated this study because of the negative outcome with ES.
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