Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Unknown status

CT.gov ID

NCT01540656

Collaborator

Rigshospitalet, Denmark (Other)

Enrollment

Locations

Arms

Duration (Months)

19.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Radical Prostatectomy	Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 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) 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. Other Names: FERTI CARE personel, Multicept A/S, Albertslund, Danmark TMNS
Active Comparator: Group 2 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) 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. Other Names: FERTI CARE personel, Multicept A/S, Albertslund, Danmark TMNS

Arm

Intervention/Treatment

Active Comparator: Group 1

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)

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.

Other Names:

FERTI CARE personel, Multicept A/S, Albertslund, Danmark

TMNS

Active Comparator: Group 2

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)

Other Names:

FERTI CARE personel, Multicept A/S, Albertslund, Danmark

TMNS

Outcome Measures

Primary Outcome Measures

24 hour Diaper test (weight in grams) at 6 weeks [Assessment at baseline and again after 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).

Secondary Outcome Measures

24 hour Diaper test (weight in grams) at 12 weeks [Assessment at baseline and again after 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 ).
Micturition diary [Assessment at baseline after 6 weeks and again after 12 weeks]
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).
Validated symptom score (ICI-Q) [Assessment at baseline after 6 weeks and again after 12 weeks]
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).
International Prostate symptom score (I-PSS)questionnaire [Assessment at baseline after 6 weeks and again after 12 weeks]
The total score as well as storage and voiding domains are evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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