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Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Phase 3
18 Years
Open (Enrolling)
Urinary Incontinence, Radical Prostatectomy

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Trial Information

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Inclusion Criteria:

- Men who have undergone a radical prostatectomy at least 1 year prior to enrollment

- Incontinence induced by the surgery (at least 8 g/24 hours)

- Capable of understanding study information and following treatment

Exclusion Criteria:

- Incontinence before radical prostatectomy

- Treatment with anticholinergic medications

- Radiation or hormone treatment

- Previous surgical treatment of incontinence

- Acute illness (including infection, trauma and haematuria)

- Faecal incontinence

- Known neurological disease

- Known Bladder pathology on cystoscopy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

24 hour Diaper test (weight in grams) at 6 weeks

Outcome Description:

Participants will be provided diapers and they will wear them for 24 hours. The weight of all used diapers is then measured to assess how much urine is leaking. The main outcome measure is the difference in leakage between groups 1 and 2 at 6 weeks (when group 1 has received treatment and group 2 has not).

Outcome Time Frame:

Assessment at baseline and again after 6 weeks

Safety Issue:


Principal Investigator

Mikkel Fode, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Copenhagen University Hospital at Herlev


Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:




Start Date:

June 2012

Completion Date:

January 2014

Related Keywords:

  • Urinary Incontinence
  • Radical Prostatectomy
  • Stress incontinence
  • Incontinence
  • prostate cancer
  • Radical Prostatectomy vibration
  • nerve stimulation
  • Urinary Incontinence