Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Conditions
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Urinary Incontinence, Radical Prostatectomy

Intervention / Treatment
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* Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study. | Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)<br>* A medical vibrator (FERTI CARE personal, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the frenulum of the glans penis. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks.<br>* Other names: TMNS;|
| Active Comparator: Group 2<br>This group will receive delayed TMNS treatment beginning at the 6 week point of the study and ending at 12 weeks. | Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)<br>* A medical vibrator (FERTI CARE personal, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the frenulum of the glans penis. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks.<br>* Other names: TMNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress incontinence, Incontinence, prostate cancer, Radical Prostatectomy vibration, nerve stimulation