Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
18 Years
N/A
Male
Urinary Incontinence, Radical Prostatectomy
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:
Interventional
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:
No
Principal Investigator
Mikkel Fode, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Copenhagen University Hospital at Herlev
Authority:
Denmark: The Danish National Committee on Biomedical Research Ethics
Study ID:
H-2-2011-118
NCT ID:
NCT01540656
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
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