Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Urinary Incontinence Clinical Trial

Official title:

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01540656
• Other study ID #: H-2-2011-118
• 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

• Radical Prostatectomy
• Urinary Incontinence

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