NCT01540656

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Radical Prostatectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-02-29
• Last updated: 2013-05-24

Locations

2 sites across 1 country: Denmark