Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial

Status unconfirmed · Not applicable

Conditions studied: Overactive Bladder

In brief

Approximately 20 Study Sites will participate over total 24 months. Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months. Primary Study Objectives: 1. To assess efficacy of the StimRouter stimulation in improving OAB symptoms of urgency and frequency as measured by Patient Voiding Diary when targeting the posterior tibial nerve 2. To assess safety of the StimRouter therapy for the indication of OAB Secondary Study Objective: To evaluate efficacy of the StimRouter therapy in addressing urinary urge incontinence as measured by the Patient Voiding Diary Study Design is prospective, multi-center, randomized, double-blinded Primary Endpoint: The primary efficacy endpoint will be the difference between the investigational and control groups in proportion of responders, where Responder is defined as having ≥50% improvement in average voiding frequency above the normal value of 8 (those returning to normal voiding based on 7-day average voids/leak episodes \< 9, will be categorized as achieving half or more reduction) AND having ≥50% improvement in average number of moderate to severe urgency episodes, at approximately three months after programming. Secondary Endpoint: Secondary endpoint will be the difference between the investigational and control groups in proportion of patients with reduction by half or more in urinary urge incontinence as measured by the average number of urge incontinence episodes per day.

Key facts

Study ID

NCT02873312

Run by

Bioness Inc

People needed

180

Starts

2017-02-10

Expected to finish

2021-07-30

Last updated by the study team

2021-01-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 3 weeks prior to the implant and for the entire study period and not to change dosages/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 with ability 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 of contraception 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, 5 and 6 months after starting external device usage
• Willing to complete a Patient Voiding Diary for 7 consecutive days prior to implant and 7 consecutive days before each follow-up visit, with moderate to severe urge component at Baseline

You may not qualify if…

• Neurogenic bladder
• Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH), treated or untreated, with ongoing significant obstruction
• Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
• Urinary tract, bladder or vaginal infection or inflammation
• More than minimal level of stress incontinence or mixed incontinence with stress component 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 the implant
• 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 of birth control
• Skin lesions or compromised skin at the implant or stimulation site
• Use of investigational drug or device therapy or participation in any study involving or 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, sacral nerve 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 to confound study
• Requirement for serial MRIs
• Presence of a documented condition or abnormality that could compromise the safety of the patient
• Life expectancy of less than 1 year

Where it is running

• Kaiser Permanente Reserach — Irvine, California, United States (enrolling)
• Cleveland Clinic Glickman Urologic and Kidney Institute — Cleveland, Ohio, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• Meridian Clinical Research, LLC/Urology Associates Savannah — Savannah, Georgia, United States (enrolling)
• Providence St. John's Health Center — Santa Monica, California, United States (enrolling)
• Northern Alberta Urology Center — Edmonton, Alberta, Canada (enrolling)
• Silverado Research, Inc — Victoria, British Columbia, Canada (enrolling)
• Toronto Western Hospital — Toronto, Ontario, Canada (enrolling)
• University of Sherbrooke — Sherbrooke, Quebec, Canada (enrolling)
• Skyline Urology — Sherman Oaks, California, United States (enrolling)
• Sheldon Freedman, MD LTD — Las Vegas, Nevada, United States
• Barrett Cowan, MD, Urology Associates — Englewood, Colorado, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• Comprehensive Urologic Care — Barrington, Illinois, United States
• Del Sol Research — Tucson, Arizona, United States
• University of North Carolina Urogynecology — Chapel Hill, North Carolina, United States
• Basel Hassoun — Oklahoma City, Oklahoma, United States
• Michael England, MD, Texas Health Care — Fort Worth, Texas, United States
• Michael DeBakey VA Med Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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