Clinical trial NCT01369485: Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder
Official title: Multi-center, Prospective, Randomized, Double-blind, Sham-controlled Clinical Study to Evaluate Safety and Effectiveness of a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Subjects With Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Urinary Incontinence
Overactive Bladder
Frequency
Urgency
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
Collaborators: name: Novella Clinical
name: Data & Inference, Inc.
First posted: 2011-06-09
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
timeFrame: 12 weeks (Randomized Phase) and 12 Months (Open Label)
measure: Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
timeFrame: 12 weeks (Randomized Phase) and 12 Months (Open Label)
Secondary outcomes:
measure: Measure Change in the Median of the Mean Urinary Frequency
timeFrame: 12 weeks and 12 Months
measure: Measure Median Change in Mean Volume Per Void
timeFrame: 12 weeks
measure: Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes
timeFrame: 12 weeks
measure: Measure Improvement in the Median of the Mean OAB-Symptom Composite Score
timeFrame: 12 weeks
measure: Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12
timeFrame: 12 Weeks (Randomized Phase) and 12 Months (Open Label).
measure: Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.
timeFrame: 12 Weeks (Randomized Phase) and 12 Months (Open Label Phase)
measure: Assessment of Treatment Benefit Scale (TBS)
timeFrame: 12 Weeks
measure: Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)
timeFrame: 12 weeks
measure: Change Clinical Global Impressions at 12 Weeks
timeFrame: 12 weeks (Randomized Phase) and 12 Months (Open Label Phase)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urologic Specialists
state: Arizona
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Washington
country: United States
facility: GW Medical Faculty Associates
state: District of Columbia
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Pompano Beach
country: United States
facility: Urology Center of Florida
state: Florida
city: Oak Lawn
country: United States
facility: Women's Health Institute of Illlinois, Ltd
state: Illinois
city: Jeffersonville
country: United States
facility: 1st Urology, PSC dba Metropolitan Urology
state: Indiana
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists, P.A.
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research
state: South Carolina
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Medical Group - Milwaukee Urogynecology
state: Wisconsin
Study officials:
affiliation: McKay Urology
name: Michael Kennelly, MD
role: PRINCIPAL_INVESTIGATOR
References: