Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

May 23, 2013 updated by: Copenhagen University Hospital at Herlev

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Copenhagen University Hospital
      • Herlev, Denmark, 2730
        • Department of Urology, Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour Diaper test (weight in grams) at 6 weeks
Time Frame: 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).
Assessment at baseline and again after 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour Diaper test (weight in grams) at 12 weeks
Time Frame: 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 ).
Assessment at baseline and again after 12 weeks
Micturition diary
Time Frame: 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).
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

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).
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
The total score as well as storage and voiding domains are evaluated
Assessment at baseline after 6 weeks and again after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (ESTIMATE)

February 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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