Sandra Engberg1, Susan Cohen, Susan M Sereika. 1. School of Nursing, University of Pittsburgh, 440 Victoria Bldg, 3500 Victoria St, Pittsburgh, PA 15261, USA. sje1@pitt.edu
Abstract
PURPOSE: The propose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the efficacy of acupuncture in treating urge and mixed urinary incontinence (UI) and the feasibility of performing the planned study procedures. We also sought to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving general health-related and disease-specific quality of life and if a sham acupuncture needle is an effective placebo intervention. DESIGN: This pilot study was a double-blinded, randomized, clinical trial. Subjects were randomly assigned to a true or sham (placebo control) acupuncture group. Both true and sham acupuncture treatments were performed twice a week for 6 weeks. All subjects were evaluated at the completion of the 6-week intervention and 4 weeks later. SAMPLE: The sample consisted of 9 women between the ages of 44 and 66 years with urge or mixed urge and stress UI at least twice a week for a minimum of 3 months. MEASURES: Subjects completed a 1-week bladder diary at baseline and at 1 and 4 weeks postacupuncture to assess the impact of acupuncture on incontinence episodes. Quality of life was measured at baseline and at 1 and 4 weeks postacupuncture using the Medical Outcomes Short-Form (general health- related quality of life) and the Incontinence Impact Questionnaire and Urogenital Distress Inventory (incontinence-specific quality of life). RESULTS: It was feasible to recruit subjects and perform the planned study procedures. Subjects randomized to the true acupuncture group had a mean 63.30% (median = 65.99%) reduction in daytime accidents/day at 1 week postacupuncture and 67.47% reduction (median = 75.76%) at 4 weeks postacupuncture. In contrast, the mean reduction in daytime accidents was 18.88% (median = 19.64%) at 1 week and 16.67% (median = 0%) at 4 weeks post-sham acupuncture. There were no significant group differences in changes in the scores on the quality-of-life measures. Subjects' perceptions about whether they had received the true or sham acupuncture were not significantly better than one would expect by chance. CONCLUSIONS: The findings of this pilot study support the need for additional research examining the efficacy of acupuncture in the treatment of UI in women, the feasibility of performing study procedures, and the use of a sham needle as placebo in acupuncture studies.
RCT Entities:
PURPOSE: The propose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the efficacy of acupuncture in treating urge and mixed urinary incontinence (UI) and the feasibility of performing the planned study procedures. We also sought to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving general health-related and disease-specific quality of life and if a sham acupuncture needle is an effective placebo intervention. DESIGN: This pilot study was a double-blinded, randomized, clinical trial. Subjects were randomly assigned to a true or sham (placebo control) acupuncture group. Both true and sham acupuncture treatments were performed twice a week for 6 weeks. All subjects were evaluated at the completion of the 6-week intervention and 4 weeks later. SAMPLE: The sample consisted of 9 women between the ages of 44 and 66 years with urge or mixed urge and stress UI at least twice a week for a minimum of 3 months. MEASURES: Subjects completed a 1-week bladder diary at baseline and at 1 and 4 weeks postacupuncture to assess the impact of acupuncture on incontinence episodes. Quality of life was measured at baseline and at 1 and 4 weeks postacupuncture using the Medical Outcomes Short-Form (general health- related quality of life) and the Incontinence Impact Questionnaire and Urogenital Distress Inventory (incontinence-specific quality of life). RESULTS: It was feasible to recruit subjects and perform the planned study procedures. Subjects randomized to the true acupuncture group had a mean 63.30% (median = 65.99%) reduction in daytime accidents/day at 1 week postacupuncture and 67.47% reduction (median = 75.76%) at 4 weeks postacupuncture. In contrast, the mean reduction in daytime accidents was 18.88% (median = 19.64%) at 1 week and 16.67% (median = 0%) at 4 weeks post-sham acupuncture. There were no significant group differences in changes in the scores on the quality-of-life measures. Subjects' perceptions about whether they had received the true or sham acupuncture were not significantly better than one would expect by chance. CONCLUSIONS: The findings of this pilot study support the need for additional research examining the efficacy of acupuncture in the treatment of UI in women, the feasibility of performing study procedures, and the use of a sham needle as placebo in acupuncture studies.
Authors: Shilpadevi Patil; Sudipta Sen; Matthew Bral; Shanthi Reddy; Kevin K Bradley; Elyse M Cornett; Charles J Fox; Alan David Kaye Journal: Curr Pain Headache Rep Date: 2016-04
Authors: James C Forde; Edward Jaffe; Benjamin V Stone; Alexis E Te; Geo Espinosa; Bilal Chughtai Journal: Int Urogynecol J Date: 2016-01-06 Impact factor: 2.894