IncontinencePhase 2FMSNCT02091947
Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
A Phase 2 study testing FMS (Magstim rapid2) in people with Incontinence, run by vghtpe user at 1 site in Taiwan.
Trial summary
Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Incontinence
- What is being tested?
- FMS (Magstim rapid2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Jun 2014
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urine incontinence refractory to traditional treatment
Who cannot join
- Arrhythmia, pacemaker implantation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veteran General Hospital
Taipei, 11217
Po-Yi Tsai, MD
Po-Yi Tsai, MD
About this study
Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.
Read the detailed description
5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.
- Conditions
- Incontinence
- Being tested
- FMS (Magstim rapid2)
- Keywords
- FMS, Urine incontinence
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMS (Magstim rapid2)Device
5 Hz FMS, over bilateral sacral roots.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays. Receives: Device: FMS (Magstim rapid2) |
| sham group | Sham comparator | sham FMS, 5 Hz, 20 min per day, for 10 weekdays. Receives: Device: FMS (Magstim rapid2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scoring on Urge-Urinary Distress Inventory questionnaire
Measured: up to 5 months
Secondary outcomes (1)
Cystometry and stress urethral pressure profile as measures of objective incontinence improvement
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startNov 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- vghtpe user
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Po-Yi Tsai, MD, Principal investigator, Dep of PMR, Taipei VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091947
- Sponsor's protocol ID
- 201010015OB
- Acronym
- FMS
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsai PY, Wang CP, Hsieh CY, Tsai YA, Yeh SC, Chuang TY. Long-term sacral magnetic stimulation for refractory stress urinary incontinence. Arch Phys Med Rehabil. 2014 Dec;95(12):2231-8. doi: 10.1016/j.apmr.2014.07.010. Epub 2014 Jul 27.
PubMed 25073008
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02091947
- Acronym / sponsor ID
- FMS / 201010015OB
- Conditions
- Incontinence
- Keywords
- FMS, Urine incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- vghtpe userOther government
- Study start
- Nov 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 19 Mar 2014 (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.
Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.
Detailed description
5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: FMS (Magstim rapid2)Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays. |
| sham group | Sham comparator | Device: FMS (Magstim rapid2)sham FMS, 5 Hz, 20 min per day, for 10 weekdays. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urine incontinence refractory to traditional treatment
Key exclusion criteria (1 listed)
- Arrhythmia, pacemaker implantation
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 |
|---|---|---|
| FMS (Magstim rapid2)5 Hz FMS, over bilateral sacral roots. | Device | experimental group, sham group |
Primary outcome
Symptom scoring on Urge-Urinary Distress Inventory questionnaire
Time frame: up to 5 months
1 secondary outcome
Cystometry and stress urethral pressure profile as measures of objective incontinence improvement
Time frame: up to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
- Derived from this study: PubMed 25073008Tsai PY, Wang CP, Hsieh CY, Tsai YA, Yeh SC, Chuang TY. Long-term sacral magnetic stimulation for refractory stress urinary incontinence. Arch Phys Med Rehabil. 2014 Dec;95(12):2231-8. doi: 10.1016/j.apmr.2014.07.010. Epub 2014 Jul 27.
Related trials for Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
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.
Po-Yi Tsai, MD principal investigator
Dep of PMR, Taipei VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMS (Magstim rapid2) in people with Incontinence, run by vghtpe user at 1 site in Taiwan.
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 1 inclusion and 1 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 19 Mar 2014. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Po-Yi Tsai, MD (886-28757293, pytsai@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom scoring on Urge-Urinary Distress Inventory questionnaire (time frame: up to 5 months). 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 NCT02091947, 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 19 Mar 2014.