An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence: a randomized, double-blind, controlled trial

Objective: To evaluate a new pattern of electrical of electrical stimulatio n 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 n ew pattern of stimulation or sham stimulation. Main outcome measures: Patients were assessed pre, mid and post treatment u sing: 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 Inventor y. Results: No significant between-group differences were highlighted except w hen 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 e ndurance characteristics of the pelvic floor musculature, although these ch anges were not translated into a reduction in symptoms. Conclusion: Although promising, the improvement in pelvic floor function di d not result in a reduction in symptoms in all patients. Further research i s required to investigate the effects of the new stimulation in combination with pelvic floor exercises and to compare the new stimulation pattern wit h existing forms of electrical stimulation.