Overactive BladderNCT01125722
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
A study testing Non-invasive neurostimulation device in people with Overactive Bladder, run by Ethicon Endo-Surgery at 11 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Non-invasive neurostimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Apr 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy the following criteria in order to be enrolled in the study:
- Males and Females, at least 18 years of age
- Documented symptoms of idiopathic overactive bladder for at least 6 months
- Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug
- An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
- An average of eight (8) or more voids per 24-hours, confirmed by the 3-day baseline voiding diary
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- Demonstrated ability to adequately complete the 3-day baseline voiding diary
- Willing and capable of understanding and complying with all requirements of the protocol
- Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Urinary retention
- Clinically significant bladder outlet obstruction
- Morbidly obese, defined as having BMI > 40 kg/m2
- Stress predominant mixed urinary incontinence
- Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.
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- History of epilepsy
- Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
- Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months
- Failure of previous neuromodulation therapy for overactive bladder
- Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
- Any clinically significant congenital or acquired disorder of the urogenital tract (including denovo OAB following sub-urethral sling)
- Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ Prolapse Quantification (POPQ) criteria.
- Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
- History of pelvic radiation therapy
- Any skin conditions affecting treatment or assessment of the treatment sites
- History of lower back surgery or injury that could impact placement of the patch, or where underlying scar tissue or nerve damage may impact treatment.
- Unable to operate the device remote control.
- Lacking dexterity to properly utilize the components of the device system.
- Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
- Any metallic implant in the back.
- Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
- History of dementia or Alzheimer's disease.
- Known latex allergies
- Uncontrolled diabetes and/or diabetes with peripheral neuropathy.
- Transurethral instrumentation within the preceding month.
- Scheduled for any of the following during the course of the study: Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), X-ray, Ultrasound, or Radiotherapy (targeting full body or back region)
- Recurrent Urinary Tract Infections (>3 UTI's in the past year)
- Clean catch Urinalysis results >10wbc/hpf
- History of or current lower tract genitourinary malignancies
- Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States9 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
McKay Urology
Charlotte, North Carolina, 28207
Alliance Urology Specialists, P.A.
Greensboro, North Carolina, 27403
AdvanceMed Research
Lawrenceville, New Jersey, 08648
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, 08054
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
William Beaumont Hospital - Department of Urology
Royal Oak, Michigan, 48073
Medical Faculty Associates, The George Washington University
Washington D.C., District of Columbia, 20037
Wheaton Franciscan Medical Group, Milwaukee Urogynecology
Wauwatosa, Wisconsin, 53226
About this study
Official title: Pilot Clinical Trial to Study the Effectiveness of a Four-week Exposure to a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence in Subjects With Idiopathic Overactive Bladder (OAB)
The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.
Read the detailed description
While the precise cause of OAB symptoms (urge, frequency, incontinence) is not clear, most physicians and researchers accept the theory that a problem in the communication between the central nervous system and the bladder is a factor.
Research has shown that a process called neuromodulation of the nerves controlling the bladder can overcome this communication problem. In patients who have symptoms caused by the communication problem, neuromodulation has been clinically proven to eliminate or significantly reduce those symptoms. While neuromodulation has been previously achieved by implanting an electrode near the sacral nerve in the spine, the new concept under investigation within this protocol is believed to achieve a similar effect from adhesive electrodes placed on the skin over spinal nerves in the lower back.
- Conditions
- Overactive Bladder
- Being tested
- Non-invasive neurostimulation device
- Keywords
- Urinary Incontinence, Overactive Bladder, Frequency, Urgency
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive neurostimulation deviceDevice
Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator.
Non-invasive neurostimulation deviceDevice
Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject.
| Study group | Role | What they receive |
|---|---|---|
| Investigator Placement Group | Active comparator | Not described Receives: Device: Non-invasive neurostimulation device |
| Subject Placement Group | Active comparator | Not described Receives: Device: Non-invasive neurostimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Daily Urgency Incontinence Episodes
Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Measured: From baseline to Week 4 of active treatment
Secondary outcomes (4)
Change in Mean Daily Voiding Frequency
Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Measured: From baseline to Week 4 of active treatment
Change in Mean Volume Per Void
Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Measured: From Baseline to Week 4 of active treatment
Change in Mean Urgency Episodes Per Day
Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Measured: From Baseline to Week 4 of active treatment
Change in Mean Overactive Bladder Symptom Composite Score
The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.
Measured: From Baseline to Week 4 of active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical, Data & Inference, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashwani Monga, BM BS, MRCOG, Principal investigator, Princess Anne Hospital, Southampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125722
- Sponsor's protocol ID
- CI-10-0001
- Status last verified
- Nov 2012
- First submitted
- 14 May 2010
- Last updated
- 17 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial to Study the Effectiveness of a Four-week Exposure to a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence in Subjects With Idiopathic Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT01125722
- Acronym / sponsor ID
- CI-10-0001
- Conditions
- Overactive Bladder
- Keywords
- Urinary Incontinence, Overactive Bladder, Frequency, Urgency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Collaborators
- Novella Clinical, Data & Inference, Inc.
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Posted 17 Dec 2012
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 determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.
Detailed description
While the precise cause of OAB symptoms (urge, frequency, incontinence) is not clear, most physicians and researchers accept the theory that a problem in the communication between the central nervous system and the bladder is a factor.
Research has shown that a process called neuromodulation of the nerves controlling the bladder can overcome this communication problem. In patients who have symptoms caused by the communication problem, neuromodulation has been clinically proven to eliminate or significantly reduce those symptoms. While neuromodulation has been previously achieved by implanting an electrode near the sacral nerve in the spine, the new concept under investigation within this protocol is believed to achieve a similar effect from adhesive electrodes placed on the skin over spinal nerves in the lower back.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigator Placement Group | Active comparator | Device: Non-invasive neurostimulation device |
| Subject Placement Group | Active comparator | Device: Non-invasive neurostimulation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Potential subjects must satisfy the following criteria in order to be enrolled in the study:
- Males and Females, at least 18 years of age
- Documented symptoms of idiopathic overactive bladder for at least 6 months
- Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug
- An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
Key exclusion criteria (31 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Urinary retention
- Clinically significant bladder outlet obstruction
- Morbidly obese, defined as having BMI > 40 kg/m2
- Stress predominant mixed urinary 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 |
|---|---|---|
| Non-invasive neurostimulation deviceActive electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator. | Device | Investigator Placement Group |
| Non-invasive neurostimulation deviceActive electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject. | Device | Subject Placement Group |
Primary outcome
Change in Mean Daily Urgency Incontinence Episodes
Time frame: From baseline to Week 4 of active treatment
Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
4 secondary outcomes
Change in Mean Daily Voiding Frequency
Time frame: From baseline to Week 4 of active treatment
Change in Mean Volume Per Void
Time frame: From Baseline to Week 4 of active treatment
Change in Mean Urgency Episodes Per Day
Time frame: From Baseline to Week 4 of active treatment
Change in Mean Overactive Bladder Symptom Composite Score
Time frame: From Baseline to Week 4 of active treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Overactive Bladder
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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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UCon Treatment of Overactive Bladder (OAB) in Males
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Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
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RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
Ashwani Monga, BM BS, MRCOG principal investigator
Princess Anne Hospital, Southampton, UK
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive neurostimulation device in people with Overactive Bladder, run by Ethicon Endo-Surgery at 11 sites in 3 countries.
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 31 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Sweden, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Daily Urgency Incontinence Episodes (time frame: From baseline to Week 4 of active treatment). 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 17 Dec 2012.