Clinical trial NCT01540656: Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
Official title: Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Urinary Incontinence
Radical Prostatectomy
Keywords: Stress incontinence
Incontinence
prostate cancer
Radical Prostatectomy vibration
nerve stimulation
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2012-02-29
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a radical prostatectomy have shown promising results. A randomized investigation of TMNS applied in the immediate period after a radical prostatectomy to investigate effects on both continence and erectile function is on going.

The present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated. The participants will be randomized to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.

The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing normal continence in men after a radical prostatectomy.


Eligibility criteria: 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

Primary outcomes:
measure: 24 hour Diaper test (weight in grams) at 6 weeks
timeFrame: Assessment at baseline and again after 6 weeks
Secondary outcomes:
measure: 24 hour Diaper test (weight in grams) at 12 weeks
timeFrame: Assessment at baseline and again after 12 weeks
measure: Micturition diary
timeFrame: Assessment at baseline after 6 weeks and again after 12 weeks
measure: Validated symptom score (ICI-Q)
timeFrame: Assessment at baseline after 6 weeks and again after 12 weeks
measure: International Prostate symptom score (I-PSS)questionnaire
timeFrame: Assessment at baseline after 6 weeks and again after 12 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
city: Herlev
country: Denmark
facility: Department of Urology, Herlev Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Mikkel Fode, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fode M, Sonksen J. Penile vibratory stimulation in the treatment of post-prostatectomy incontinence: a randomized pilot study. Neurourol Urodyn. 2015 Feb;34(2):117-22. doi: 10.1002/nau.22536. Epub 2013 Nov 27.