Urinary Incontinence, UrgePhase 3ELEC STIMNCT01464372
Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder
A Phase 3 study testing Electrical Field Stimulation Device in people with Urinary Incontinence, Urge, run by EMKinetics, Inc.
Trial summary
The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- Electrical Field Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jan 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
- Urinary Urge Incontinence
- Urinary Frequency
Who cannot join
- Primary complaint of Stress Incontinence
- Neurogenic bladder
- Overflow Incontinence
- Functional Incontinence
About this study
Official title: Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- Electrical Field Stimulation Device, Sham Nerve Stimulation Device
- Keywords
- Urinary Incontinence, Urge, Peripheral Nerve Stimulation
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Field Stimulation DeviceDevice
Treatment with Electrical Field Stimulation Device
Sham Nerve Stimulation DeviceDevice
Use of the sham device
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Treatment using electrical field stimulation of peripheral nerves Receives: Device: Electrical Field Stimulation Device |
| Sham Device | Sham comparator | Control group using sham device to mimic sound and sensation of investigational device Receives: Device: Sham Nerve Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
Measured: One week after final treatment visit
No Serious Adverse Events or Unanticipated Adverse Device Effects
Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
Measured: First treatment through follow-up (one week after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMKinetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Peters, MD, Principal investigator, Birmingham Urologic AssociatesScott MacDiarmid, MD, Principal investigator, Alliance Urology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464372
- Sponsor's protocol ID
- EMK0910
- Acronym
- ELEC STIM
- Status last verified
- Jan 2013
- First submitted
- 31 Oct 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
- ClinicalTrials.gov ID
- NCT01464372
- Acronym / sponsor ID
- ELEC STIM / EMK0910
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Urinary Incontinence, Urge, Peripheral Nerve Stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants (actual)
- Lead sponsor
- EMKinetics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Nov 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.
The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Electrical Field Stimulation DeviceTreatment using electrical field stimulation of peripheral nerves |
| Sham Device | Sham comparator | Device: Sham Nerve Stimulation DeviceControl group using sham device to mimic sound and sensation of investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urinary Urge Incontinence
- Urinary Frequency
Key exclusion criteria (4 listed)
- Primary complaint of Stress Incontinence
- Neurogenic bladder
- Overflow Incontinence
- Functional Incontinence
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 |
|---|---|---|
| Electrical Field Stimulation DeviceTreatment with Electrical Field Stimulation Device | Device | Investigational Device |
| Sham Nerve Stimulation DeviceUse of the sham device | Device | Sham Device |
Primary outcome
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
Time frame: One week after final treatment visit
Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
No Serious Adverse Events or Unanticipated Adverse Device Effects
Time frame: First treatment through follow-up (one week after last treatment)
Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Related trials for Urinary Incontinence, Urge
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Urge Urinary 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.
Kenneth Peters, MD principal investigator
Birmingham Urologic Associates
Scott MacDiarmid, MD principal investigator
Alliance Urology Specialists
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electrical Field Stimulation Device in people with Urinary Incontinence, Urge, run by EMKinetics, Inc.
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 2 inclusion and 4 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 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. 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?
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm (time frame: One week after final treatment visit). 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?
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 31 Jan 2013.