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

Last updated: January 27, 2021
Sponsor: Bioness Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Overactive Bladder

Enuresis

Treatment

N/A

Clinical Study ID

NCT02873312
CP-STMR-OAB-002
  • Ages > 22
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female age ≥22 years and competent to provide consent
  2. Minimum 3 months of self-reported OAB symptoms
  3. A mean score of ≥4.0 on the OAB-q symptom questions 1-8
  4. Diagnosis of OAB with Overactive Bladder Symptom Score (OABSS) ≥ 8.0
  5. Average urinary frequency of ≥ 10 daily voids associated with urgency
  6. Able to tolerate and sense tibial nerve stimulation
  7. 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
  8. Failed/inadequate response to first- and second-line therapy for OAB
  9. 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
  10. Able to toilet self and have and maintain good personal hygiene
  11. Able to utilize the StimRouter system independently
  12. Negative urine dipstick result (no UTI detected)
  13. 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.)
  14. Able to provide clear, thoughtful responses to questions and questionnaires
  15. Willing to visit office for device programming and clinical evaluations at 1, 2, 3, 5and 6 months after starting external device usage
  16. 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:

  1. Neurogenic bladder
  2. Urinary tract mechanical obstruction including but not limited to Benign ProstaticHyperplasia (BPH), treated or untreated, with ongoing significant obstruction
  3. Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) orsurgery in past 12 months
  4. Urinary tract, bladder or vaginal infection or inflammation
  5. More than minimal level of stress incontinence or mixed incontinence with stresscomponent likely to confound study outcome
  6. Type I diabetes or uncontrolled Type II diabetes
  7. Allergy to local anesthetic or adhesives
  8. Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before theimplant
  9. 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
  10. Skin lesions or compromised skin at the implant or stimulation site
  11. Use of investigational drug or device therapy or participation in any study involvingor impacting gynecologic, urinary or renal function within past 4 weeks
  12. Implanted neurostimulator, pacemaker, or defibrillator
  13. Current use of TENS in pelvic region, back or leg
  14. Current or prior use of electrical stimulation therapy for OAB (e.g. PTNS, sacralnerve stimulation, pelvic floor muscle stimulation or biofeedback)
  15. Metallic implant below knee, within 6 inches of proposed site for implanted lead
  16. Prior vaginal mesh or similar surgery that has not abolished stress incontinence,intravaginal pessaries, or other evidence of stress incontinence significant enough toconfound study
  17. Requirement for serial MRIs
  18. Presence of a documented condition or abnormality that could compromise the safety ofthe patient
  19. Life expectancy of less than 1 year

Study Design

Total Participants: 180
Study Start date:
February 10, 2017
Estimated Completion Date:
July 30, 2021

Study Description

Approximately 180 subjects will be enrolled in the Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder study. After signing the informed consent and completing the screening visit, eligible candidates will be asked to (1) stop any OAB medications (including but not limited to anti-muscarinic medication or tricyclic antidepressants (TCA) as well as stabilize dosage and frequency of any concomitant medications for 3 weeks, if applicable, and then (2) complete a daily Patient Voiding Diary for 7 days .

Subjects will then return to the office for baseline review. If all screening and baseline criteria are met, the subject will be enrolled, randomized in a 1:1 ratio into either the "control group" or the "investigational group" and scheduled for implant with the StimRouter device.

After approximately 3 weeks for healing post-implant, study participants will be programmed according to their randomization assignment. All subjects will be instructed to apply stimulation at least 3 days/week for at least 30 minutes/day (i.e., the minimum protocol requirements for device use) for 6 months and to apply stimulation when they anticipate OAB events. Patient Voiding Diaries will be completed by the participants for 7 days prior to each follow-up visit and provided to the office at each follow-up visit. Follow-up visits will occur at Month 1, Month 2, Month 3, Month 5 and Month 6. Each follow-up visit will include the review of subject voiding diaries and the completion of other subject questionnaires for measuring OAB and quality of life assessments. Final follow-up evaluations for all subjects will occur at Month 6.

Connect with a study center

  • Northern Alberta Urology Center

    Edmonton, Alberta T6G1Z1
    Canada

    Active - Recruiting

  • Silverado Research, Inc

    Victoria, British Columbia V8T2C1
    Canada

    Active - Recruiting

  • Toronto Western Hospital

    Toronto, Ontario M5T258
    Canada

    Active - Recruiting

  • University of Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Del Sol Research

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Saad Juma, MD Genesis Health Care

    Encinitas, California 92024
    United States

    Site Not Available

  • Kaiser Permanente Reserach

    Irvine, California 92618
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • Providence St. John's Health Center

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Skyline Urology

    Sherman Oaks, California 91411
    United States

    Active - Recruiting

  • Barrett Cowan, MD, Urology Associates

    Englewood, Colorado 80113
    United States

    Completed

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Completed

  • Meridian Clinical Research, LLC/Urology Associates Savannah

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Comprehensive Urologic Care

    Barrington, Illinois 60010
    United States

    Completed

  • Sheldon Freedman, MD LTD

    Las Vegas, Nevada 89144
    United States

    Completed

  • University of North Carolina Urogynecology

    Chapel Hill, North Carolina 27514
    United States

    Completed

  • Cleveland Clinic Glickman Urologic and Kidney Institute

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Basel Hassoun

    Oklahoma City, Oklahoma 73120
    United States

    Completed

  • Michael England, MD, Texas Health Care

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Michael DeBakey VA Med Ctr

    Houston, Texas 77030
    United States

    Site Not Available

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