CONTEXT: Pelvic floor electrical stimulation (PFES) has been shown to be effective for stress incontinence. However, its role in a multicomponent behavioral training program has not been defined. OBJECTIVE: To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence. DESIGN AND SETTING: Prospective randomized controlled trial conducted from October 1, 1995, through May 1, 2001, at a university-based outpatient continence clinic in the United States. PATIENTS: Volunteer sample of 200 ambulatory, nondemented, community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern; stratified by race, type of incontinence (stress only vs mixed), and severity (frequency of episodes). INTERVENTIONS: Patients were randomly assigned to 8 weeks (4 visits) of behavioral training, 8 weeks (4 visits) of the behavioral training plus home PFES, or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition). MAIN OUTCOME MEASURES: Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries. Secondary outcomes were patient satisfaction and changes in quality of life. RESULTS: Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6% with behavioral training, 71.9% with behavioral training plus PFES, and 52.5% with the self-help booklet (P =.005). In comparison with the self-help booklet, behavioral training (P =.02) and behavioral training plus PFES (P =.002) were significantly more effective, but they were not significantly different from each other (P =.60). The PFES group had significantly better patient self-perception of outcome (P<.001) and satisfaction with progress (P =.02). Significant improvements were seen across all 3 groups on the Incontinence Impact Questionnaire but with no between-group differences. CONCLUSIONS: Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence. A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs.
RCT Entities:
CONTEXT: Pelvic floor electrical stimulation (PFES) has been shown to be effective for stress incontinence. However, its role in a multicomponent behavioral training program has not been defined. OBJECTIVE: To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence. DESIGN AND SETTING: Prospective randomized controlled trial conducted from October 1, 1995, through May 1, 2001, at a university-based outpatient continence clinic in the United States. PATIENTS: Volunteer sample of 200 ambulatory, nondemented, community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern; stratified by race, type of incontinence (stress only vs mixed), and severity (frequency of episodes). INTERVENTIONS:Patients were randomly assigned to 8 weeks (4 visits) of behavioral training, 8 weeks (4 visits) of the behavioral training plus home PFES, or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition). MAIN OUTCOME MEASURES: Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries. Secondary outcomes were patient satisfaction and changes in quality of life. RESULTS: Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6% with behavioral training, 71.9% with behavioral training plus PFES, and 52.5% with the self-help booklet (P =.005). In comparison with the self-help booklet, behavioral training (P =.02) and behavioral training plus PFES (P =.002) were significantly more effective, but they were not significantly different from each other (P =.60). The PFES group had significantly better patient self-perception of outcome (P<.001) and satisfaction with progress (P =.02). Significant improvements were seen across all 3 groups on the Incontinence Impact Questionnaire but with no between-group differences. CONCLUSIONS: Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence. A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs.
Authors: Holly E Richter; Kathryn L Burgio; Linda Brubaker; Ingrid E Nygaard; Wen Ye; Alison Weidner; Catherine S Bradley; Victoria L Handa; Diane Borello-France; Patricia S Goode; Halina Zyczynski; Emily S Lukacz; Joseph Schaffer; Matthew Barber; Susan Meikle; Cathie Spino Journal: Obstet Gynecol Date: 2010-03 Impact factor: 7.661
Authors: Leslee L Subak; Rena Wing; Delia Smith West; Frank Franklin; Eric Vittinghoff; Jennifer M Creasman; Holly E Richter; Deborah Myers; Kathryn L Burgio; Amy A Gorin; Judith Macer; John W Kusek; Deborah Grady Journal: N Engl J Med Date: 2009-01-29 Impact factor: 91.245
Authors: Julien Labrie; Yolanda van der Graaf; Eric Buskens; Stella E S M Tiersma; Huub C H van der Vaart Journal: BMC Womens Health Date: 2009-09-01 Impact factor: 2.809
Authors: S E Lamb; J Pepper; R Lall; E C Jørstad-Stein; M D Clark; L Hill; J Fereday-Smith Journal: BMC Womens Health Date: 2009-09-14 Impact factor: 2.809