Urinary IncontinencePhase 3NCT01540656
Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
A Phase 3 study testing Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE) in people with Urinary Incontinence and Radical Prostatectomy, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Radical Prostatectomy
- What is being tested?
- Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2012to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
Department of Urology, Herlev Hospital
Herlev, 2730
About this study
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.
Read more
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
- Being tested
- Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)
- Keywords
- Stress incontinence, Incontinence, prostate cancer, Radical Prostatectomy vibration, nerve stimulation
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)Device
Also called FERTI CARE personel, Multicept A/S, Albertslund, Danmark, TMNS
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study. Receives: 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. Receives: Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessment at baseline and again after 6 weeks
Secondary outcomes (4)
24 hour Diaper test (weight in grams) at 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 ).
Measured: Assessment at baseline and again after 12 weeks
Micturition diary
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).
Measured: Assessment at baseline after 6 weeks and again after 12 weeks
Validated symptom score (ICI-Q)
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).
Measured: Assessment at baseline after 6 weeks and again after 12 weeks
International Prostate symptom score (I-PSS)questionnaire
The total score as well as storage and voiding domains are evaluated
Measured: Assessment at baseline after 6 weeks and again after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Mikkel Fode, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540656
- Sponsor's protocol ID
- H-2-2011-118
- Status last verified
- May 2013
- First submitted
- 23 Feb 2012
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24285576
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
- ClinicalTrials.gov ID
- NCT01540656
- Acronym / sponsor ID
- H-2-2011-118
- Conditions
- Urinary Incontinence, Radical Prostatectomy
- Keywords
- Stress incontinence, Incontinence, prostate cancer, Radical Prostatectomy vibration, nerve stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study. |
| Group 2 | Active comparator | Device: Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)This group will receive delayed TMNS treatment beginning at the 6 week point of the study and ending at 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Incontinence before radical prostatectomy
- Treatment with anticholinergic medications
- Radiation or hormone treatment
- Previous surgical treatment of incontinence
- Acute illness (including infection, trauma and haematuria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)Also: FERTI CARE personel, Multicept A/S, Albertslund, Danmark, TMNSA 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. | Device | Group 1, Group 2 |
Primary outcome
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).
4 secondary outcomes
24 hour Diaper test (weight in grams) at 12 weeks
Time frame: Assessment at baseline and again after 12 weeks
Micturition diary
Time frame: 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
International Prostate symptom score (I-PSS)questionnaire
Time frame: Assessment at baseline after 6 weeks and again after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Derived from this study: PubMed 24285576Fode 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Fode, MD principal investigator
Copenhagen University Hospital at Herlev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE) in people with Urinary Incontinence and Radical Prostatectomy, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour Diaper test (weight in grams) at 6 weeks (time frame: Assessment at baseline and again after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2013.