Overview

This trial is active, not recruiting.

Conditions urinary incontinence, radical prostatectomy
Treatment transcutaneous mechanical nerve stimulation (tmns) (ferti care)
Phase phase 3
Sponsor Copenhagen University Hospital at Herlev
Collaborator Rigshospitalet, Denmark
Start date June 2012
End date January 2014
Trial size 39 participants
Trial identifier NCT01540656, H-2-2011-118

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study.
transcutaneous mechanical nerve stimulation (tmns) (ferti care) FERTI CARE personel, Multicept A/S, Albertslund, Danmark
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.
(Active Comparator)
This group will receive delayed TMNS treatment beginning at the 6 week point of the study and ending at 12 weeks.
transcutaneous mechanical nerve stimulation (tmns) (ferti care) FERTI CARE personel, Multicept A/S, Albertslund, Danmark
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.

Primary Outcomes

Measure
24 hour Diaper test (weight in grams) at 6 weeks
time frame: Assessment at baseline and again after 6 weeks

Secondary Outcomes

Measure
24 hour Diaper test (weight in grams) at 12 weeks
time frame: Assessment at baseline and again after 12 weeks
Micturition diary
time frame: Assessment at baseline after 6 weeks and again after 12 weeks
Validated symptom score (ICI-Q)
time frame: Assessment at baseline after 6 weeks and again after 12 weeks
International Prostate symptom score (I-PSS)questionnaire
time frame: Assessment at baseline after 6 weeks and again after 12 weeks

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
Principal investigator Mikkel Fode, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Copenhagen University Hospital at Herlev.