title: Pelvic floor electrical stimulation in the treatment of stress incontinence: an investigational study and a placebo controlled double-blind trial.
abstract: OBJECTIVE
  We designed an investigational study and a placebo controlled, double-blind study to evaluate the usefulness of electrical pelvic stimulation in stress incontinence.
  
  
  METHODS
  We studied 44 patients with stress incontinence (six men and 38 women, age 63 +/- 13), including 9 patients in the investigational study and 35 in the double-blind study. We used 50 Hz. square waves of 1 ms. pulse duration for stimulation. A vaginal electrode was used in women and an anal electrode in men. Urethral pressure profile before, during and after 15-minute stimulation was measured in the investigational study. In the double-blind trial an active device and a dummy device were used, and efficacy was judged from patient impressions, records in frequency/volume chart, results of 1-hour pad test and urodynamic parameters after 4-week treatment.
  
  
  RESULTS
  In the investigational study maximum urethral closure pressure (mean plus or minus standard deviation) before, during and after stimulation was 44.4 +/- 17.5, 64.5 +/- 28.8 and 46.8 +/- 25.6 cm. water, respectively. This parameter significantly increased (p = 0.0275) during stimulation. In the double-blind trial patient impressions were good in 60% of the active device group and 8% of the dummy device group (p = 0.0051). For the pad test significant improvement was noted in the active device group (p = 0.0100). Cure rate was 45% in the active device group and 7.7% in the dummy device group. There were significantly more cured or improved patients for frequency of leakage (p = 0.0196) and pad test (p = 0.0100).
  
  
  CONCLUSIONS
  Electrical stimulation is effective for the treatment of stress incontinence.
authors.affiliation: Department of Urology, Chiba University School of Medicine, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yamanishi
authors.forename: K
authors.initials: K
authors.lastname: Yasuda
authors.forename: R
authors.initials: R
authors.lastname: Sakakibara
authors.forename: T
authors.initials: T
authors.lastname: Hattori
authors.forename: H
authors.initials: H
authors.lastname: Ito
authors.forename: S
authors.initials: S
authors.lastname: Murakami
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000295:instrumentation; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017773:Pelvic Floor; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000628:therapy*; D014563:Urodynamics