Erectile DysfunctionPhase 3NCT01067261
Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy
A Phase 3 study testing Transcutaneous mechanical nerve stimulation (TMNS) and Pelvic floor muscle training in people with Erectile Dysfunction and Urinary Incontinence, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
Trial summary
After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side effects in the form of incontinence and erectile dysfunction. It has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (TMNS) done through… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Urinary Incontinence
- What is being tested?
- Transcutaneous mechanical nerve stimulation (TMNS) and Pelvic floor muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2010to Mar 2013
- 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
- Scheduled to undergo nerve sparing radical prostatectomy
- Continent before surgery
- A minimum score on the IIEF-questionnaire of 18
- Sexually active
Who cannot join
- Treatment with nitrates
- Treatment with α-blockers
- Serious cardiovascular disease
- Severely reduced liver function,
- Retinitis pigmentosa,
- Non-arteritic ischemic optic neuropathy (NAION)
- Previous vascular infarction of the eye
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Urology, Aarhus University Hospital, Skejby
Aarhus N, DK-8200
Department of Urology, Herlev University Hospital
Herlev, DK- 2730
About this study
After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side effects in the form of incontinence and erectile dysfunction.
It has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will examine the effect of TMNS in the preservation and restoration of urinary continence and erectile function and in the treatment of urinary incontinence and erectile dysfunction in conjunction with radical prostatectomy.
Read more
The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the penis which may improve their function and there by prevent or minimize the occurrence of incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to eliminate these symptoms once they have occurred. It is possible that TMNS will also directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of this tissue. In case the improved nerve function is not great enough to secure satisfactory erectile function in itself it may still improve the effect of PDE-5-inhibitors.
In pilot studies TMNS has already shown an effect in the treatment of urinary continence.
In this study the patients will be randomized to either TMNS treatment or no TMNS treatment. In both groups the patients will participate in a pelvic floor muscle training program. In the group receiving active treatment this will be supplemented by TMNS treatment. The two groups will be evaluated and compared with regard to erectile function time to continence after surgery.
- Conditions
- Erectile Dysfunction, Urinary Incontinence
- Being tested
- Transcutaneous mechanical nerve stimulation (TMNS), Pelvic floor muscle training
- Keywords
- Nerve stimulation, TMNS, Prostatectomy, Prevention, Restoration, Treatment, Vibration, Non-invasive
- Medical subject headings
- Erectile Dysfunction, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous mechanical nerve stimulation (TMNS)Device
Also called FERTI CARE personel, Multicept A/S, Albertslund, Danmark
Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)
A medical vibrator (FERTI CARE personel, 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. A stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used. The treatment will be initiated 1 to 4 weeks before the radical prostatectomy and re-initiated 0 to 14 days after the operation. The treatment will then continue for 6 weeks. The stimulation will be preformed daily by the patients in their own homes.
Pelvic floor muscle trainingOther
Regular pelvic floor training which is offered to all patients undergoing a radical prostatectomy at Herlev Hospital.
| Study group | Role | What they receive |
|---|---|---|
| TMNS and pelvic floor muscle training | Experimental | This group will receive both the normal pelvic floor muscle training and the TMNS vibration therapy following their radical prostatectomy. Treatment with TMNS will start before the surgery and continue 6 weeks after the surgery. Receives: Device: Transcutaneous mechanical nerve stimulation (TMNS) |
| Pelvic floor muscle training only | Active comparator | This group will receive the normal pelvic floor muscle training after prostatectomy only. Receives: Other: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function score by a validated symptom questionnaire (IIEF)
Measured: At 3 months, 6 months and 1 year
Time to continence after surgery
Measured: At 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2013
- Study completionMar 2013
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 Erectile DysfunctionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Velux Fonden
- Responsible party
- Sponsor
- Investigators
- Jens R Sønksen, MD, Ph.D, Study director, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067261
- Sponsor's protocol ID
- HC-2008-127
- Status last verified
- Dec 2012
- First submitted
- 10 Feb 2010
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fode M, Borre M, Ohl DA, Lichtbach J, Sonksen J. Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial. BJU Int. 2014 Jul;114(1):111-7. doi: 10.1111/bju.12501. Epub 2014 Jan 22.
PubMed 24127838
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
- Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01067261
- Acronym / sponsor ID
- HC-2008-127
- Conditions
- Erectile Dysfunction, Urinary Incontinence
- Keywords
- Nerve stimulation, TMNS, Prostatectomy, Prevention, Restoration, Treatment, Vibration, Non-invasive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Velux Fonden
- Study start
- Feb 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Feb 2010 (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.
After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side effects in the form of incontinence and erectile dysfunction.
It has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will examine the effect of TMNS in the preservation and restoration of urinary continence and erectile function and in the treatment of urinary incontinence and erectile dysfunction in conjunction with radical prostatectomy.
The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the penis which may improve their function and there by prevent or minimize the occurrence of incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to eliminate these symptoms once they have occurred. It is possible that TMNS will also directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of this tissue. In case the improved nerve function is not great enough to secure satisfactory erectile function in itself it may still improve the effect of PDE-5-inhibitors.
In pilot studies TMNS has already shown an effect in the treatment of urinary continence.
In this study the patients will be randomized to either TMNS treatment or no TMNS treatment. In both groups the patients will participate in a pelvic floor muscle training program. In the group receiving active treatment this will be supplemented by TMNS treatment. The two groups will be evaluated and compared with regard to erectile function time to continence after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMNS and pelvic floor muscle training | Experimental | Device: Transcutaneous mechanical nerve stimulation (TMNS)This group will receive both the normal pelvic floor muscle training and the TMNS vibration therapy following their radical prostatectomy. Treatment with TMNS will start before the surgery and continue 6 weeks after the surgery. |
| Pelvic floor muscle training only | Active comparator | Other: Pelvic floor muscle trainingThis group will receive the normal pelvic floor muscle training after prostatectomy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo nerve sparing radical prostatectomy
- Continent before surgery
- A minimum score on the IIEF-questionnaire of 18
- Sexually active
Key exclusion criteria (7 listed)
- Treatment with nitrates
- Treatment with α-blockers
- Serious cardiovascular disease
- Severely reduced liver function,
- Retinitis pigmentosa,
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)Also: FERTI CARE personel, Multicept A/S, Albertslund, DanmarkDevice: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark) A medical vibrator (FERTI CARE personel, 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. A stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used. The treatment will be initiated 1 to 4 weeks before the radical prostatectomy and re-initiated 0 to 14 days after the operation. The treatment will then continue for 6 weeks. The stimulation will be preformed daily by the patients in their own homes. | Device | TMNS and pelvic floor muscle training |
| Pelvic floor muscle trainingRegular pelvic floor training which is offered to all patients undergoing a radical prostatectomy at Herlev Hospital. | Other | Pelvic floor muscle training only |
Primary outcome
Erectile function score by a validated symptom questionnaire (IIEF)
Time frame: At 3 months, 6 months and 1 year
Time to continence after surgery
Time frame: At 3 months, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Derived from this study: PubMed 24127838Fode M, Borre M, Ohl DA, Lichtbach J, Sonksen J. Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial. BJU Int. 2014 Jul;114(1):111-7. doi: 10.1111/bju.12501. Epub 2014 Jan 22.
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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.
Jens R Sønksen, MD, Ph.D study director
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) and Pelvic floor muscle training in people with Erectile Dysfunction and Urinary Incontinence, 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 4 inclusion and 7 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Erectile function score by a validated symptom questionnaire (IIEF) (time frame: At 3 months, 6 months and 1 year). The study lists 2 primary outcomes in all. 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 NCT01067261, 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.