Phase
Condition
Overactive Bladder
Enuresis
Treatment
N/AClinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female age ≥22 years and competent to provide consent
- Minimum 3 months of self-reported OAB symptoms
- A mean score of ≥4.0 on the OAB-q symptom questions 1-8
- Diagnosis of OAB with Overactive Bladder Symptom Score (OABSS) ≥ 8.0
- Average urinary frequency of ≥ 10 daily voids associated with urgency
- Able to tolerate and sense tibial nerve stimulation
- Willing to discontinue OAB and/or tricyclic antidepressant (TCA) medications for 3weeks prior to the implant and for the entire study period and not to changedosages/frequency of all others for 3 weeks prior to the implant
- Failed/inadequate response to first- and second-line therapy for OAB
- Body mass index (BMI) < 31 or investigator does not expect BMI to interfere withability to place the implant or negatively impact healing at implant site
- Able to toilet self and have and maintain good personal hygiene
- Able to utilize the StimRouter system independently
- Negative urine dipstick result (no UTI detected)
- If female of child-bearing age, willing to use a medically-acceptable method ofcontraception for the duration of the study (e.g. oral contraceptives, condoms, shot,patch, etc.)
- Able to provide clear, thoughtful responses to questions and questionnaires
- Willing to visit office for device programming and clinical evaluations at 1, 2, 3, 5and 6 months after starting external device usage
- Willing to complete a Patient Voiding Diary for 7 consecutive days prior to implantand 7 consecutive days before each follow-up visit, with moderate to severe urgecomponent at Baseline
Exclusion
Exclusion Criteria:
- Neurogenic bladder
- Urinary tract mechanical obstruction including but not limited to Benign ProstaticHyperplasia (BPH), treated or untreated, with ongoing significant obstruction
- Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) orsurgery in past 12 months
- Urinary tract, bladder or vaginal infection or inflammation
- More than minimal level of stress incontinence or mixed incontinence with stresscomponent likely to confound study outcome
- Type I diabetes or uncontrolled Type II diabetes
- Allergy to local anesthetic or adhesives
- Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before theimplant
- Pregnant, lactating, planning to become pregnant, given birth in the past 12 months,or female of child-bearing potential and not practicing a medically-approved method ofbirth control
- Skin lesions or compromised skin at the implant or stimulation site
- Use of investigational drug or device therapy or participation in any study involvingor impacting gynecologic, urinary or renal function within past 4 weeks
- Implanted neurostimulator, pacemaker, or defibrillator
- Current use of TENS in pelvic region, back or leg
- Current or prior use of electrical stimulation therapy for OAB (e.g. PTNS, sacralnerve stimulation, pelvic floor muscle stimulation or biofeedback)
- Metallic implant below knee, within 6 inches of proposed site for implanted lead
- Prior vaginal mesh or similar surgery that has not abolished stress incontinence,intravaginal pessaries, or other evidence of stress incontinence significant enough toconfound study
- Requirement for serial MRIs
- Presence of a documented condition or abnormality that could compromise the safety ofthe patient
- Life expectancy of less than 1 year
Study Design
Study Description
Connect with a study center
Northern Alberta Urology Center
Edmonton, Alberta T6G1Z1
CanadaActive - Recruiting
Silverado Research, Inc
Victoria, British Columbia V8T2C1
CanadaActive - Recruiting
Toronto Western Hospital
Toronto, Ontario M5T258
CanadaActive - Recruiting
University of Sherbrooke
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Del Sol Research
Tucson, Arizona 85710
United StatesSite Not Available
Saad Juma, MD Genesis Health Care
Encinitas, California 92024
United StatesSite Not Available
Kaiser Permanente Reserach
Irvine, California 92618
United StatesActive - Recruiting
University of Southern California
Los Angeles, California 90089
United StatesActive - Recruiting
Providence St. John's Health Center
Santa Monica, California 90404
United StatesActive - Recruiting
Skyline Urology
Sherman Oaks, California 91411
United StatesActive - Recruiting
Barrett Cowan, MD, Urology Associates
Englewood, Colorado 80113
United StatesCompleted
Clinical Research Center of Florida
Pompano Beach, Florida 33060
United StatesCompleted
Meridian Clinical Research, LLC/Urology Associates Savannah
Savannah, Georgia 31405
United StatesActive - Recruiting
Comprehensive Urologic Care
Barrington, Illinois 60010
United StatesCompleted
Sheldon Freedman, MD LTD
Las Vegas, Nevada 89144
United StatesCompleted
University of North Carolina Urogynecology
Chapel Hill, North Carolina 27514
United StatesCompleted
Cleveland Clinic Glickman Urologic and Kidney Institute
Cleveland, Ohio 44195
United StatesActive - Recruiting
Basel Hassoun
Oklahoma City, Oklahoma 73120
United StatesCompleted
Michael England, MD, Texas Health Care
Fort Worth, Texas 76104
United StatesSite Not Available
Michael DeBakey VA Med Ctr
Houston, Texas 77030
United StatesSite Not Available
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