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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01540656
Other study ID # H-2-2011-118
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received February 23, 2012
Last updated May 23, 2013
Start date June 2012
Est. completion date January 2014

Study information

Verified date May 2013
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)
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.

Locations

Country Name City State
Denmark Rigshospitalet, Copenhagen University Hospital Copenhagen
Denmark Department of Urology, Herlev Hospital Herlev

Sponsors (2)

Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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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