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Trial record 3 of 4 for:    stimrouter

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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Bioness Inc
Sponsor:
Information provided by (Responsible Party):
Bioness Inc
ClinicalTrials.gov Identifier:
NCT02873312
First received: August 10, 2016
Last updated: July 11, 2017
Last verified: July 2017
  Purpose

Approximately 10 US Study Sites will participate over total 18 months Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months.

Primary Study Objective

  1. To assess efficacy of the StimRouter stimulation therapy 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

Secondary Study Objective

To evaluate:

Efficacy of the StimRouter stimulation therapy in decreasing specific OAB symptoms of urgency, frequency, and urinary urge incontinence as measured by the Global Response Assessment (GRA) and 7-day 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, defined as a return to normal voiding (7-day average in voids/leak episodes < 8) OR > 50% improvement in average voiding frequency above 8 that patient had at baseline OR > 50% improvement in average number of moderate to severe urgency episodes at approximately three months after programming as measured by 7-day Patient Voiding Diary.

Primary Outcomes:

  1. Proportion of responders based on Patient Voiding Diary
  2. Adverse Event Reports

Secondary Endpoints:

The secondary efficacy endpoint will be the difference in specific OAB symptoms of urgency, frequency, and urinary urge incontinence as measured based on (1) the difference in proportion of subjects in the investigational and control groups who have moderately or markedly improved overall response on a 7 level Global Response Assessment (GRA) at approximately three months after programming; and (2) the difference in responses on the 7-day Patient Voiding Diary between the baseline visit and approximately three months after programming.

Secondary Outcomes:

  1. Global Response Assessment (GRA)
  2. Urgency, frequency, and urinary urge incontinence as measured by Daily Patient Voiding Diary

Condition Intervention
Overactive Bladder Device: StimRouter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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)

Resource links provided by NLM:


Further study details as provided by Bioness Inc:

Primary Outcome Measures:
  • 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.

  • 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:
  • Global Response Assesment [ Time Frame: Baseline, Month 3 ]
    The Global Response Assessment (GRA) is a 7-level assessment tool with specific GRA subset symptom components (urgency, frequency and urinary urge incontinence). The 7-level GRA measures bladder symptoms ranging from "Markedly-Worsened" to "Markedly-Improved" (Peters et al., 2008). The GRA score will be assessed approximately 3 months after programming to determine overall OAB symptom changes with StimRouter therapeutic treatment as compared to control group sensory level treatment.


Estimated Enrollment: 120
Actual Study Start Date: February 10, 2017
Estimated Study Completion Date: March 15, 2018
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: StimRouter Treatment
The Treatment group will receive active StimRouter electrical stimulation. At the end of the Month 3 visit the Treatment group will continue to receive active 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 (sensory 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

Detailed Description:

Approximately 120 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 Month6.

  Eligibility

Ages Eligible for Study:   22 Years and older   (Adult, Senior)
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. Self-reported failed/inadequate response to first- and second-line therapy for OAB
  9. Body mass index (BMI) < 30 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

Exclusion Criteria:

  1. Neurogenic bladder
  2. Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
  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. 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 the knee
  16. Prior vaginal mesh or similar surgery, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Reserach Recruiting
Tucson, Arizona, United States, 85710
Contact: Elvia Parra    520-257-3881    eparra@delosolresearch.com   
Contact: Nayeli Jimenez    520-257-3881    Njimenez@delsolresearch.com   
United States, California
Saad Juma, MD Genesis Health Care Recruiting
Encinitas, California, United States, 92024
Contact: Drina Robinson    760-753-8373    erobinson@genhp.com   
Contact: Melinda Garcilaso    760-753-8373    mgarcilaso@genhp.com   
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, 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: Lynessa Vandever    702-7320-0282    lvandever@freedmanurology.com   
United States, North Carolina
University of North Carolina Urogynecology Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Betty Rupp    919-843-8114    brupp@med.unc.edu   
Principal Investigator: Elizabeth Geller, MD         
Sub-Investigator: Ellen Wells, MD         
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 Recruiting
Fort Worth, Texas, United States, 76104
Contact: Elizabeth Weaver    817-923-5559    eweaver@txhealthcare.com   
Contact: Michael England, MD    817-923-5559    mengland@txhealthcare.com   
Baylor College of Medicine 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         
Sponsors and Collaborators
Bioness Inc
Investigators
Study Chair: Keith McBride Bioness Inc
Principal Investigator: Roger Dmochowski, MD Vanderbilt University
Study Director: Charlene Myers, BS Bioness Inc
  More Information

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT02873312     History of Changes
Other Study ID Numbers: CP-STMR-OAB-002
Study First Received: August 10, 2016
Last Updated: July 11, 2017
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

ClinicalTrials.gov processed this record on August 22, 2017