BACKGROUND: Conservative management, such as pelvic floor muscle training (PMFT), is commonly recommended as first-line therapy for women with stress urinary incontinence (SUI). METHODS: We randomly assigned 245 women with SUI to 12 weeks ofcircular muscle exercises (Paula method) or PMFT in order to assess whether these approaches are equivalent. End points after 12 weeks included urinary leak as measured by a 1-hour pad test, subjective assessment of incontinence, and quality of life (QOL). Cure was defined as urinary leakage of <1 g. RESULTS: The mean decrease in urinary leakage was 7.9 g (SD 12.1) among women in the Paula group and 8.9 g (SD 18.2) in the PFMT group (90% confidence interval [CI] of between-group difference was -4.68 g to 3.0 g). This did not meet the prespecified criterion for equivalence. There were 15.2% (p = 0.04) more cures in those randomized to the Paula method. Improvement in subjective urinary complaints and QOL was observed in both groups. The study was limited by a dropout rate of 26.6%. CONCLUSIONS: Both methods are efficacious in women with SUI. The results suggest superiority of the Paula method in terms of cure rate.
RCT Entities:
BACKGROUND: Conservative management, such as pelvic floor muscle training (PMFT), is commonly recommended as first-line therapy for women with stress urinary incontinence (SUI). METHODS: We randomly assigned 245 women with SUI to 12 weeks of circular muscle exercises (Paula method) or PMFT in order to assess whether these approaches are equivalent. End points after 12 weeks included urinary leak as measured by a 1-hour pad test, subjective assessment of incontinence, and quality of life (QOL). Cure was defined as urinary leakage of <1 g. RESULTS: The mean decrease in urinary leakage was 7.9 g (SD 12.1) among women in the Paula group and 8.9 g (SD 18.2) in the PFMT group (90% confidence interval [CI] of between-group difference was -4.68 g to 3.0 g). This did not meet the prespecified criterion for equivalence. There were 15.2% (p = 0.04) more cures in those randomized to the Paula method. Improvement in subjective urinary complaints and QOL was observed in both groups. The study was limited by a dropout rate of 26.6%. CONCLUSIONS: Both methods are efficacious in women with SUI. The results suggest superiority of the Paula method in terms of cure rate.
Authors: Ana Paula M Resende; Míriam R D Zanetti; Carla D Petricelli; Rodrigo A Castro; Sandra M Alexandre; Mary U Nakamura Journal: Int Urogynecol J Date: 2010-11-23 Impact factor: 2.894