Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01540656
First received: February 23, 2012
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Radical Prostatectomy
Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • 24 hour Diaper test (weight in grams) at 6 weeks [ Time Frame: Assessment at baseline and again after 6 weeks ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • 24 hour Diaper test (weight in grams) at 12 weeks [ Time Frame: Assessment at baseline and again after 12 weeks ] [ Designated as safety issue: No ]

    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 ).


  • Micturition diary [ Time Frame: Assessment at baseline after 6 weeks and again after 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Validated symptom score (ICI-Q) [ Time Frame: Assessment at baseline after 6 weeks and again after 12 weeks ] [ Designated as safety issue: No ]

    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).


  • International Prostate symptom score (I-PSS)questionnaire [ Time Frame: Assessment at baseline after 6 weeks and again after 12 weeks ] [ Designated as safety issue: No ]
    The total score as well as storage and voiding domains are evaluated


Enrollment: 39
Study Start Date: June 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540656

Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, 2100
Department of Urology, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Investigators
Principal Investigator: Mikkel Fode, MD Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01540656     History of Changes
Other Study ID Numbers: H-2-2011-118
Study First Received: February 23, 2012
Last Updated: May 23, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
Stress incontinence
Incontinence
prostate cancer
Radical Prostatectomy vibration
nerve stimulation

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014