title: Penile vibratory stimulation in the treatment of post-prostatectomy incontinence: a randomized pilot study.
abstract: OBJECTIVE
  To examine penile vibratory stimulation (PVS) in the treatment of post-prostatectomy urinary incontinence (UI).
  
  
  METHODS
  Patients with post-prostatectomy UI were included in a 12-week trial. A 24-hr pad test and a 72-hr voiding diary were collected at baseline. Participants were randomized to receive PVS for the first 6 weeks (group 1) or for the final 6 weeks (group 2) of the study. The primary outcome was the difference in leakage between groups 1 and 2 at 6 weeks as measured by changes in the pad test. The trial was registered at www.clinicaltrials.org (NCT01540656).
  
  
  RESULTS
  Data from 31 men were available for analyses. The difference in the change on the pad test between the groups did not reach statistical significance at 6 weeks (P = 0.13) while the change in incontinence episodes between groups approached statistical significance (P = 0.052). However, there was a median reduction of -33 g (P = 0.021) on the pad test and a median reduction in daily incontinence episodes of -1 (P = 0.023) in group 1 at 6 weeks. At 12 weeks, group 2 had a median decrease on the pad test of -8 g (P = 0.10) and no change in incontinence episodes. A pooled analysis showed a decline on the pad test of -13.5 g (P = 0.004) after PVS. Small improvements were seen in subjective symptom scores and 58% stated to be satisfied with PVS. Self-limiting side effects were experienced by 15% of patients.
  
  
  CONCLUSIONS
  PVS is feasible in the treatment of post-prostatectomy UI. Larger trials are needed to document the clinical efficacy.
authors.affiliation: Department of Urology, Herlev University Hospital, Herlev, Denmark.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Fode
authors.forename: Jens
authors.initials: J
authors.lastname: Sønksen
mesh_terms: D000368:Aged; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D016496:Incontinence Pads; D008297:Male; D008875:Middle Aged; D010413:Penis / Q000294:innervation / Q000502:physiology*; D010812:Physical Stimulation / Q000295:instrumentation* / Q000379:methods*; D010865:Pilot Projects; D011468:Prostatectomy / Q000009:adverse effects*; D057566:Self Report; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000209:etiology* / Q000628:therapy*; D014732:Vibration / Q000627:therapeutic use*
keywords: conservative treatment; incontinence; nerve stimulation; penile vibratory stimulation; prostatic neoplasms; radical prostatectomy; urinary incontinence