OBJECTIVE: To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence. DESIGN: A randomized, double-blind, controlled trial. SETTING: The study took place on three clinical sites. SUBJECTS:Patients (n = 27) with urodynamically proven stress incontinence recruited via consultant referral. INTERVENTIONS: Patients were randomly allocated to one of two groups: the new pattern of stimulation or sham stimulation. MAIN OUTCOME MEASURES: Patients were assessed pre, mid and post treatment using: perineometry, digital assessment and pad testing. The following were only used pre and post treatment: seven-day frequency/volume chart, SF-36, the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. RESULTS: No significant between-group differences were highlighted except when quality of life was assessed with the Urogenital Distress Inventory (p = 0.01). A significant reduction in scores was observed in the stimulation group (p = 0.03) However, improvements were seen in both the strength and endurance characteristics of the pelvic floor musculature, although these changes were not translated into a reduction in symptoms. CONCLUSION: Although promising, the improvement in pelvic floor function did not result in a reduction in symptoms in all patients. Further research is required to investigate the effects of the new stimulation in combination with pelvic floor exercises and to compare the new stimulation pattern with existing forms of electrical stimulation.
RCT Entities:
OBJECTIVE: To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence. DESIGN: A randomized, double-blind, controlled trial. SETTING: The study took place on three clinical sites. SUBJECTS:Patients (n = 27) with urodynamically proven stress incontinence recruited via consultant referral. INTERVENTIONS:Patients were randomly allocated to one of two groups: the new pattern of stimulation or sham stimulation. MAIN OUTCOME MEASURES: Patients were assessed pre, mid and post treatment using: perineometry, digital assessment and pad testing. The following were only used pre and post treatment: seven-day frequency/volume chart, SF-36, the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. RESULTS: No significant between-group differences were highlighted except when quality of life was assessed with the Urogenital Distress Inventory (p = 0.01). A significant reduction in scores was observed in the stimulation group (p = 0.03) However, improvements were seen in both the strength and endurance characteristics of the pelvic floor musculature, although these changes were not translated into a reduction in symptoms. CONCLUSION: Although promising, the improvement in pelvic floor function did not result in a reduction in symptoms in all patients. Further research is required to investigate the effects of the new stimulation in combination with pelvic floor exercises and to compare the new stimulation pattern with existing forms of electrical stimulation.
Authors: Sue Ross; Dana Soroka; Amalia Karahalios; Cathryn M A Glazener; E Jean C Hay-Smith; Harold P Drutz Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2005-07-16