NCT01540656

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

February 23, 2012

Last Update Submit

May 23, 2013

Conditions

Urinary IncontinenceRadical Prostatectomy

Keywords

Stress incontinenceIncontinenceprostate cancerRadical Prostatectomy vibrationnerve stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 24 hour Diaper test (weight in grams) at 12 weeks

    Assessment at baseline and again after 12 weeks

  • Micturition diary

    Assessment at baseline after 6 weeks and again after 12 weeks

  • Validated symptom score (ICI-Q)

    Assessment at baseline after 6 weeks and again after 12 weeks

  • International Prostate symptom score (I-PSS)questionnaire

    Assessment at baseline after 6 weeks and again after 12 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Group 2

ACTIVE COMPARATOR

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)

Interventions

Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)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.

Also known as: FERTI CARE personel, Multicept A/S, Albertslund, Danmark, TMNS
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Department of Urology, Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24285576DERIVED

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, StressProstatic Neoplasms

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesProstatic Diseases

Study Officials

  • Mikkel Fode, MD

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

DK(2)