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

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ClinicalTrials.gov Identifier: NCT02873312
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Bioness Inc

Brief 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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Device: StimRouter Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The implanting investigator, the study subjects, and the individuals who assess the outcome measures for each subject will be blinded to the subjects' randomization groups. Each study site's programmers will be unblinded to the randomization assignment and will receive each subject's randomization assignment. The programmers will then set the stimulation parameters and train the subjects on device use.
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: StimRouter Neuromodulation System




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873312


Contacts
Contact: Keith McBride (661) 362-4866 keith.mcbride@bioness.com
Contact: Samantha Valla (661) 902-5334 samantha.valla@bioness.com

Locations
United States, Arizona
Del Sol Research Withdrawn
Tucson, Arizona, United States, 85710
United States, California
Kaiser Permanente Reserach Recruiting
Irvine, California, United States, 92618
Contact: Tiffany Castanon    626-564-3731 ext 338    Tiffany.L.Castanon@kp.org   
Principal Investigator: Emily Whitcomb, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Ileana Aldana, MPH    323-865-0702    Ileana.Aldana@med.usc.edu   
Principal Investigator: David Ginsberg, MD         
United States, Colorado
Barrett Cowan, MD, Urology Associates Recruiting
Englewood, Colorado, United States, 80113
Contact: Michelle Lexin    303-733-8848 ext 1266    M.Lexin@uradenver.com   
Contact: Lenden Neeper    (303) 733-8848 ext 1262    L.Neeper@uradenver.com   
United States, Florida
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Jordan Herman, CCRC    954-946-8873    jordan@floridacrc.com   
Principal Investigator: Steven Kester, MD         
United States, Georgia
Meridian Clinical Research, LLC/Urology Associates Savannah Recruiting
Savannah, Georgia, United States, 31405
Contact: Taryn Collett    912-443-4253    tcollett@mcrmed.com   
Principal Investigator: Buffi G Boyd, MD         
United States, Illinois
Comprehensive Urologic Care Recruiting
Barrington, Illinois, United States, 60010
Contact: Betty Anderson    847-852-4306    banderson@compurocare.com   
Contact: Ning Wu, MD    847-3825080    NWu@compurocare.com   
United States, Nevada
Sheldon Freedman, MD LTD Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Danielle Freedman    701-732-0282 ext 232    dfreedman@freedmanurology.com   
Contact    702-7320-0282    aalver@freedmanurology.com   
United States, North Carolina
University of North Carolina Urogynecology Active, not recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Cleveland Clinic Glickman Urologic and Kidney Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Andrea Aaby    216-444-1152    aabya@ccf.org   
Contact: Kathleen Dolphin, PA    216-245-5121    DOLPHIK@ccf.org   
United States, Oklahoma
Basel Hassoun Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Gary Parker    405-749-9889    gpmpkpkpaw@yahoo.com   
United States, Texas
Michael England, MD, Texas Health Care Withdrawn
Fort Worth, Texas, United States, 76104
Michael DeBakey VA Med Ctr Recruiting
Houston, Texas, United States, 77030
Contact: Sebrina Tello    713-798-8106    stello@bcm.edu   
Contact: Nellie Perez, RN    713-798-8106    nelliep@bcm.edu   
Principal Investigator: Christopher P Smith, MD         
Canada, Alberta
Northern Alberta Urology Center Recruiting
Edmonton, Alberta, Canada, T6G1Z1
Contact: Donna Moskalyk, RN    780-425-5598    donna.moskalyk@albertahealthservices.ca   
Principal Investigator: Gary Gray, MD         
Canada, British Columbia
Silverado Research, Inc Recruiting
Victoria, British Columbia, Canada, V8T2C1
Contact: Amanda Pawlowski    250-592-9998    amanda@silveradoresearch.org   
Contact: Grace Wicken    250-592-9998    admin@silveradoresearch.org   
Principal Investigator: Nathan Hoag, MD         
Canada, Ontario
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T258
Contact: Rowaa Banjar, MD    416-603-5018    Rowaa.Banjar@uhn.ca   
Contact: Dean Elterman, MD    416-603-5800    dean.elterman@uhn.ca   
Principal Investigator: Magdy Hassouna, MD         
Canada, Quebec
University of Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Elsie Morneau, BSN    819-346-1110 ext 12827    elsie.morneau.ciussse-chus@ssss.gouv.qc.ca   
Principal Investigator: Le Mai Tu, MD         
Sponsors and Collaborators
Bioness Inc
Investigators
Study Chair: Keith McBride Bioness Inc
Principal Investigator: Howard Goldman, MD The Cleveland Clinic
Study Director: Charlene Myers Bioness Inc

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT02873312     History of Changes
Other Study ID Numbers: CP-STMR-OAB-002
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms