Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder

Completed · Not applicable · Has a placebo group

Conditions studied: Overactive Bladder

In brief

The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).

Key facts

Study ID

NCT01369485

Run by

Ethicon Endo-Surgery

People needed

163

Starts

2011-06-01

Expected to finish

2013-12-01

Last updated by the study team

2014-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females, at least 18 years of age
• Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug (unless patient was contra-indicated for anti-cholinergic use)
• Symptoms of overactive bladder for at least 6 months
• An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
• Dexterity and ability to place and operate the device
• Females of child-bearing capability agrees to use a reliable form of birth control for the duration of the trial
• An average of eight (8) or more voids per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary
• Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the baseline voiding diary
• Signed and dated the IRB-approved Informed Consent document.

You may not qualify if…

• Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc)
• Morbidly obese, defined as having Body Mass Index (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 and uncontrolled 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
• Any neuromodulation therapy for overactive bladder within the past 3 months
• Failure to respond to previous neuromodulation therapy for overactive bladder
• Leading edge of any vaginal prolapse is beyond hymenel ring.
• Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
• 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.
• Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back.
• Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
• Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g., hydrogel, acrylic-based adhesive, polyurethane).
• Uncontrolled diabetes and/or diabetes with peripheral neuropathy.
• Current Urinary Tract Infection (UTI) or history of recurrent UTIs (>3 UTIs in the past year).
• History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation.
• Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study.

Where it is running

• Arizona Urologic Specialists — Tucson, Arizona, United States
• Tri Valley Urology Medical Group — Murrieta, California, United States
• GW Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Specialists in Urology — Naples, Florida, United States
• Urology Center of Florida — Pompano Beach, Florida, United States
• Women's Health Institute of Illlinois, Ltd — Oak Lawn, Illinois, United States
• 1st Urology, PSC dba Metropolitan Urology — Jeffersonville, Indiana, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University Urology Associates — New York, New York, United States
• McKay Urology — Charlotte, North Carolina, United States
• Alliance Urology Specialists, P.A. — Greensboro, North Carolina, United States
• Carolina Urologic Research — Myrtle Beach, South Carolina, United States
• Integrity Medical Research — Mountlake Terrace, Washington, United States
• Wheaton Franciscan Medical Group - Milwaukee Urogynecology — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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