Urinary Incontinence Clinical Trial
Official title:
Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
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.
Status | Active, not recruiting |
Enrollment | 39 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet, Copenhagen University Hospital | Copenhagen | |
Denmark | Department of Urology, Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital at Herlev | Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24 hour Diaper test (weight in grams) at 6 weeks | 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). |
Assessment at baseline and again after 6 weeks | No |
Secondary | 24 hour Diaper test (weight in grams) at 12 weeks | Participants will be provided diapers and they will wear them for 24 hours. The weight of all used diapers is then measured to asses how much urine is leaking. Here the leakage between groups 1 and 2 is measured at 12 weeks (when both groups have received treatment ). |
Assessment at baseline and again after 12 weeks | No |
Secondary | Micturition diary | The number of involuntary incontinence and normal micturition episodes are evaluated based on a patient diary. Here the difference in number of incontinence episodes between groups 1 and 2 are calculated at 6 weeks (when only group 1 has received treatment) and at 12 weeks (when both groups have received treatment). | Assessment at baseline after 6 weeks and again after 12 weeks | No |
Secondary | Validated symptom score (ICI-Q) | The ICI-Q symptom score includes changes in incontinence and micturition patterns and patients' subjective assessment of their symptoms. The scores are evaluated and differences between groups 1 and 2 are calculated at 6 weeks (when only group 1 has received treatment) and at 12 weeks (when both groups have received treatment). |
Assessment at baseline after 6 weeks and again after 12 weeks | No |
Secondary | International Prostate symptom score (I-PSS)questionnaire | The total score as well as storage and voiding domains are evaluated | Assessment at baseline after 6 weeks and again after 12 weeks | No |
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