Overactive BladderNCT01214265
A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder
A study testing EMKinetics non-invasive Magnetic neurostimulator in people with Overactive Bladder, run by EMKinetics, Inc at 1 site in United States.
Trial summary
To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- EMKinetics non-invasive Magnetic neurostimulator
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2010
- Phase
- Interventional
- 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 >18 years of age
- A score of > 4 on the OAB-q short form for urgency (question 1)
- Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary
- Self-reported bladder symptoms present > 3 months
- Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics.
- Off all anti-muscarinics for at least 2 weeks prior to enrollment
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- Capable of giving informed consent
- Ambulatory and able to use a toilet independently, without difficulty
- Capable and willing to follow all study-related procedures
Who cannot join
- The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.)
- The patient has an active urinary tract infection.
- Neurogenic bladder
- Botox use in bladder or pelvic floor muscles in the past year
- Pacemakers or implantable defibrillators
- Primary complaint of stress urinary incontinence
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- Current vaginal infection
- Current use of InterStim
- Current use of Bion
- Current use of TENS in the pelvic region, back or leg
- Previously been treated with PTNS
- Use of investigational drug/device therapy within the past 4 weeks
- Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
- Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination
- The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee (or permanent metallic tattoo <30cm from left ankle).
- The patient has chronic constipation (less than two (2) bowel movements per week)
- The patient has history of gastric or urinary retention
- The patient has uncontrolled diabetes
- Subjects with nerve damage, injury or surgery that would impact either tibial nerve or pelvic floor function
- The patient is unable or unwilling to sign informed consent
- The patient is currently on pharmacologic treatment that could affect bladder function
- Known Cystocele >/= to Grade 3 that has not been reduced by treatment (surgery or pessary)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Incontinence and Pelvic Support Institute
Mission Viejo, California, 92691
About this study
Official title: A Pilot Clinical Study to Evaluate the Initial Feasibility of Neuromodulation Therapy in Treating Patients With Overactive Bladder Via Magnetic Stimulation of the Posterior Tibial Nerve
To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- EMKinetics non-invasive Magnetic neurostimulator
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMKinetics non-invasive Magnetic neurostimulatorDevice
Patients will be treated with 12 weekly sessions of magnetic stimulation of the posterior tibial nerve at 20 hz using the EMKinetics non-invasive Magnetic neurostimulator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Response Assessment
Improved score on the Global Response Assessment (GRA) scale after 12 weeks of therapy. A score of 2 (moderately improved) or 3 (markedly improved) constitutes a responder on the 7 point scale
Measured: After 12 weeks of therapy
Secondary outcomes (3)
Urinary Frequency
Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks
Measured: After 12 weeks of therapy
Urinary Incontinence
Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks
Measured: After 12 weeks of therapy
Overactive Bladder Symptoms (OAB-q SF)
Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks
Measured: After 12 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMKinetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214265
- Sponsor's protocol ID
- EMK0708C
- Status last verified
- Oct 2010
- First submitted
- 1 Oct 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Evaluate the Initial Feasibility of Neuromodulation Therapy in Treating Patients With Overactive Bladder Via Magnetic Stimulation of the Posterior Tibial Nerve
- ClinicalTrials.gov ID
- NCT01214265
- Acronym / sponsor ID
- EMK0708C
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EMKinetics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Oct 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.
To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women >18 years of age
- A score of > 4 on the OAB-q short form for urgency (question 1)
- Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary
- Self-reported bladder symptoms present > 3 months
- Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics.
Key exclusion criteria (22 listed)
- The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.)
- The patient has an active urinary tract infection.
- Neurogenic bladder
- Botox use in bladder or pelvic floor muscles in the past year
- Pacemakers or implantable defibrillators
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 |
|---|---|---|
| EMKinetics non-invasive Magnetic neurostimulatorPatients will be treated with 12 weekly sessions of magnetic stimulation of the posterior tibial nerve at 20 hz using the EMKinetics non-invasive Magnetic neurostimulator. | Device | – |
Primary outcome
Global Response Assessment
Time frame: After 12 weeks of therapy
Improved score on the Global Response Assessment (GRA) scale after 12 weeks of therapy. A score of 2 (moderately improved) or 3 (markedly improved) constitutes a responder on the 7 point scale
3 secondary outcomes
Urinary Frequency
Time frame: After 12 weeks of therapy
Urinary Incontinence
Time frame: After 12 weeks of therapy
Overactive Bladder Symptoms (OAB-q SF)
Time frame: After 12 weeks of therapy
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 26 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMKinetics non-invasive Magnetic neurostimulator in people with Overactive Bladder, run by EMKinetics, Inc at 1 site in United States.
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 9 inclusion and 22 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 26 Oct 2010. 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 United States. 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.
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?
Global Response Assessment (time frame: After 12 weeks of therapy). 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 26 Oct 2010.