Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

NCT ID: NCT01540656

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-01-31

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.

Conditions

Urinary Incontinence; Radical Prostatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study.

Group Type: ACTIVE_COMPARATOR

Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)

Intervention Type: DEVICE

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.

Group 2

This group will receive delayed TMNS treatment beginning at the 6 week point of the study and ending at 12 weeks.

Group Type: ACTIVE_COMPARATOR

Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikkel Fode, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Locations

Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Department of Urology, Herlev Hospital

Herlev, , Denmark

Countries

Denmark

References

Fode M, Sonksen J. Penile vibratory stimulation in the treatment of post-prostatectomy incontinence: a randomized pilot study. Neurourol Urodyn. 2015 Feb;34(2):117-22. doi: 10.1002/nau.22536. Epub 2013 Nov 27.

Reference Type: DERIVED

PMID: 24285576 (View on PubMed)

Other Identifiers

H-2-2011-118

Identifier Type: -

Identifier Source: org_study_id