Stress Urinary IncontinencePhase 3NCT01366066
Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence
A Phase 3 study testing Transcutaneous mechanical nerve stimulation in people with Stress Urinary Incontinence and Urge Urinary Incontinence, run by Copenhagen University Hospital at Herlev at 1 site 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, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urge Urinary Incontinence
- What is being tested?
- Transcutaneous mechanical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women suffering from stress incontinence OR Women suffering from urge incontinence /overactive bladder syndrome
- Ongoing anticholinergic treatment in the urge incontinence/overactive bladder syndrome group
- Patient capable of understanding protocol and performing treatment
Who cannot join
- On going pregnancy or breast feeding
- Treatment with anticholinergic medications in the stress incontinence group
- Treatment with diuretic drugs
- Acute illness (including infection, trauma and haematuria)
- Fibromyalgia
- Faecal incontinence
Show all 11Show fewer
- Known neurological disease
- Bladder pain syndrome
- Genital prolaps > stage 2 on the Pelvic Organ Prolapse Quantification System POP-Q
- Previous treatment with neuromodulation or Botox
- Previous pelvic floor surgery or radiation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departement of Gynecology, Roskilde Hospital
Roskilde, Denmark, 4000
About this study
Official title: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Stress Incontinence and Urge Incontinence
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.
The present study aims to treat urinary incontinence and includes 2 groups of patients with 30 patients in each group: Women suffering from urinary stress incontinence and women suffering from urge incontinence. A medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. All patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications.
Read more
The stimulation will be performed at the perineum 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 a normal function of the pelvic floor muscles and bladder function in incontinent patients.
- Being tested
- Transcutaneous mechanical nerve stimulation
- Keywords
- Stress incontinence, urge incontinence, overactive bladder syndrome, vibration, nerve stimulation
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous mechanical nerve stimulationDevice
Also called 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 perineum. 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 |
|---|---|---|
| TMNS treatment - Stress incontinence | Active comparator | Women with stress incontinence treated with active TMNS (vibration) Receives: Device: Transcutaneous mechanical nerve stimulation |
| No treatment - stress incontinence | No intervention | Women with stress incontinence NOT treated with TMNS (vibration) |
| TMNS treatment - Urge incontinence | Active comparator | Women with stress incontinence treated with TMNS (vibration) Receives: Device: Transcutaneous mechanical nerve stimulation |
| No treatment - urge incontinence | No intervention | Women with urge incontinence NOT treated with TMNS (vibration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaper test - weight (grams)
Measured: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Secondary outcomes (5)
Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms
Measured: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Treatment satisfaction
Measured: After 6 weeks of treatment (when treatment is terminated)
Urethral pressure (in the stress group)
Measured: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Episodes of over active bladder during urodynamics (urge patients)
Measured: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Micturition diary - The number of involuntary incontinence and normal micturition episodes
Measured: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Failure to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Sponsor
- Investigators
- Mikkel Fode, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366066
- Sponsor's protocol ID
- H-2-2010-109
- Status last verified
- May 2013
- First submitted
- 30 May 2011
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
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 Treatment of Stress Incontinence and Urge Incontinence
- ClinicalTrials.gov ID
- NCT01366066
- Acronym / sponsor ID
- H-2-2010-109
- Keywords
- Stress incontinence, urge incontinence, overactive bladder syndrome, vibration, nerve stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- May 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 3 Jun 2011 (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.
The present study aims to treat urinary incontinence and includes 2 groups of patients with 30 patients in each group: Women suffering from urinary stress incontinence and women suffering from urge incontinence. A medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. All patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications.
The stimulation will be performed at the perineum 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 a normal function of the pelvic floor muscles and bladder function in incontinent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMNS treatment - Stress incontinence | Active comparator | Device: Transcutaneous mechanical nerve stimulationWomen with stress incontinence treated with active TMNS (vibration) |
| No treatment - stress incontinence | No intervention | –Women with stress incontinence NOT treated with TMNS (vibration) |
| TMNS treatment - Urge incontinence | Active comparator | Device: Transcutaneous mechanical nerve stimulationWomen with stress incontinence treated with TMNS (vibration) |
| No treatment - urge incontinence | No intervention | –Women with urge incontinence NOT treated with TMNS (vibration) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women suffering from stress incontinence OR Women suffering from urge incontinence /overactive bladder syndrome
- Ongoing anticholinergic treatment in the urge incontinence/overactive bladder syndrome group
- Patient capable of understanding protocol and performing treatment
Key exclusion criteria (11 listed)
- On going pregnancy or breast feeding
- Treatment with anticholinergic medications in the stress incontinence group
- Treatment with diuretic drugs
- Acute illness (including infection, trauma and haematuria)
- Fibromyalgia
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 stimulationAlso: FERTI CARE personel, Multicept A/S, Albertslund, DanmarkA 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 perineum. 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 | TMNS treatment - Stress incontinence, TMNS treatment - Urge incontinence |
Primary outcome
Diaper test - weight (grams)
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
5 secondary outcomes
Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Treatment satisfaction
Time frame: After 6 weeks of treatment (when treatment is terminated)
Urethral pressure (in the stress group)
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Episodes of over active bladder during urodynamics (urge patients)
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Micturition diary - The number of involuntary incontinence and normal micturition episodes
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Results and safety
The study was stopped early (reason given: Failure to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
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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
1 site 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 in people with Stress Urinary Incontinence and Urge Urinary Incontinence, run by Copenhagen University Hospital at Herlev at 1 site 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 11 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: stopped early, 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 1 site 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 was stopped early (reason given: Failure to recruit participants). 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?
Diaper test - weight (grams) (time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.