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

January 27, 2021 updated by: Bioness Inc

Prospective, Multi-Center, Randomized, Double-Blinded Trial of Percutaneous Tibial Nerve Stimulation With the Bioness StimRouter Neuromodulation System Versus Sham in the Treatment of Overactive Bladder (OAB)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z1
    • British Columbia
      • Victoria, British Columbia, Canada, V8T2C1
    • Ontario
      • Toronto, Ontario, Canada, M5T258
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Magdy Hassouna, MD
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Withdrawn
        • Del Sol Research
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente Reserach
        • Contact:
        • Principal Investigator:
          • Emily Whitcomb, MD
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • David Ginsberg, MD
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence St. John's Health Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Philippe Langevin, MD
      • Sherman Oaks, California, United States, 91411
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Completed
        • Barrett Cowan, MD, Urology Associates
    • Florida
      • Pompano Beach, Florida, United States, 33060
        • Completed
        • Clinical Research Center of Florida
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Meridian Clinical Research, LLC/Urology Associates Savannah
        • Contact:
        • Principal Investigator:
          • Buffi G Boyd, MD
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Completed
        • Comprehensive Urologic Care
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Completed
        • Sheldon Freedman, MD Ltd
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Completed
        • University of North Carolina Urogynecology
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Glickman Urologic and Kidney Institute
        • Contact:
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Completed
        • Basel Hassoun
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Withdrawn
        • Michael England, MD, Texas Health Care
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Michael DeBakey VA Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
  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 with ability 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 of contraception 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, 5 and 6 months after starting external device usage
  16. 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

Exclusion Criteria:

  1. Neurogenic bladder
  2. Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH), treated or untreated, with ongoing significant obstruction
  3. Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery 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 stress component 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 the implant
  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 of birth 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 involving or 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, sacral nerve 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 to confound study
  17. Requirement for serial MRIs
  18. Presence of a documented condition or abnormality that could compromise the safety of the patient
  19. Life expectancy of less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: StimRouter Treatment
The Treatment group will receive therapeutic level StimRouter electrical stimulation. At the end of the Month 3 visit the Treatment group will continue to receive therapeutic level StimRouter electrical stimulation for an additional 3 months.
Device: StimRouter

The StimRouter System is a neuromodulation system consisting of the following components and accessories:

  • An implantable multi-electrode lead with integrated receiver in loader and surgical tools for implantation of the implantable lead.
  • An external programming system with a clinician programmer, a clinician programmer cradle and charger, an external pulse transmitter tester and accessories.
  • A patient-operated system with an external pulse transmitter (StimRouter EPT), a disposable StimRouter Electrode, an external patient programmer and charger, and accessories.
Other Names:
  • StimRouter Neuromodulation System
Sham Comparator: StimRouter Control
The Control group will receive sham (sub-therapeutic level only) StimRouter stimulation. At the end of the Month 3 visit the Control group will be allowed to receive therapeutic level StimRouter electrical stimulation for 3 months.
Device: StimRouter

The StimRouter System is a neuromodulation system consisting of the following components and accessories:

  • An implantable multi-electrode lead with integrated receiver in loader and surgical tools for implantation of the implantable lead.
  • An external programming system with a clinician programmer, a clinician programmer cradle and charger, an external pulse transmitter tester and accessories.
  • A patient-operated system with an external pulse transmitter (StimRouter EPT), a disposable StimRouter Electrode, an external patient programmer and charger, and accessories.
Other Names:
  • StimRouter Neuromodulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1) Patient Voiding Diary
Time Frame: Baseline, Month 3
The daily Patient Voiding Diary is a self-reported record and it includes how frequently the patient intentionally urinates during the day (frequency) and is awakened to urinate at night (nighttime void frequency), amount voided, number of urgency episodes, voids with moderate to severe urgency, urinary urge incontinence episodes and the degree of urgency to urinate. The 7-day daily Patient Voiding Diary will be assessed at baseline and at approximately 3 months after programming to measure total number of voids (frequency) and voids with moderate-to-severe urgency.The average for each of the seven-day periods will be calculated and compared.
Baseline, Month 3
Adverse Events reported cumulatively throughout study
Time Frame: Baseline through Month 6
Occurrence of anticipated and unanticipated adverse events will be documented, accumulated and reported for the duration of the study
Baseline through Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seven-Day Patient Voiding Diary
Time Frame: Baseline, Month 3
The 7-day daily Patient Voiding Diary will be assessed at baseline and at approximately 3 months after programming to measure urinary urge incontinence episodes.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioness Inc

Investigators

  • Principal Investigator: Howard Goldman, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2017

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-STMR-OAB-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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