title: Evaluation of a new disposable "tampon like" electrostimulation technology (Pelviva®) for the treatment of urinary incontinence in women: a 12-week single blind randomized controlled trial.
abstract: OBJECTIVE
  To test the null hypothesis that a novel disposable "tampon like" electrostimulation device (Pelviva(®)) is no better than unsupervised pelvic floor muscle exercise for treatment of urinary incontinence in women.
  
  
  METHODS
  Pre/post-intervention assessor blinded, single center RCT. A total of 123 community dwelling self referred women with symptoms of stress, urge, or mixed incontinence were randomly assigned to one of two 12-week duration treatments: Pelviva(®) used for 30 min a day plus unsupervised pelvic floor muscle exercise or unsupervised exercises alone. Outcome measures included ICIQ-UI (primary), ICIQ FLUTSex and global impression of severity and improvement (secondary) completed at recruitment, after 4 weeks of unsupervised exercise and immediately post-treatment. Diary of exercise frequency/type, overall impression, and usage of device was completed mid- and post-treatment.
  
  
  RESULTS
  Pelviva(®) plus exercise produced significantly better outcome than unsupervised exercise alone: 5 points (45%) versus 1 point (10%) for ICIQ-UI (P = 0.014); 67% versus 33% for leak frequency (P = 0.005); 40% versus 20% for leak interference with life (P = 0.018). Incontinence was less bothersome during sex to a greater extent in the Pelviva(®) group (P = 0.026). Women were enthusiastic about the device, found it comfortable/easy to use and experienced no adverse events.
  
  
  CONCLUSIONS
  The Pelviva(®) device plus unsupervised exercise is more successful than unsupervised pelvic floor muscle exercise alone in treating urinary incontinence. The device is easy/comfortable to use, there are no apparent adverse incidents, and women can manage their incontinence in the privacy of their own home. The product will be launched 2013.
authors.affiliation: Centre for Rehabilitation Science, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom. jackie.oldham@manchester.ac.uk
authors.forename: Jackie
authors.initials: J
authors.lastname: Oldham
authors.forename: Julia
authors.initials: J
authors.lastname: Herbert
authors.forename: Kathryn
authors.initials: K
authors.lastname: McBride
mesh_terms: D000328:Adult; D004209:Disposable Equipment; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000295:instrumentation*; D004739:England; D004867:Equipment Design; D005260:Female; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008875:Middle Aged; D009119:Muscle Contraction; D017060:Patient Satisfaction; D017773:Pelvic Floor / Q000503:physiopathology; D011788:Quality of Life; D020127:Recovery of Function; D012720:Severity of Illness Index; D012725:Sexual Behavior; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D053202:Urinary Incontinence, Urge / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*