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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 : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bioness Inc

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE February 10, 2017
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02873312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial
Official Title  ICMJE 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)
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Overactive Bladder
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: StimRouter
  • 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.
    Intervention: Device: StimRouter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
180
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Keith McBride (661) 362-4866 keith.mcbride@bioness.com
Contact: Samantha Valla (661) 902-5334 samantha.valla@bioness.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02873312
Other Study ID Numbers  ICMJE CP-STMR-OAB-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bioness Inc
Study Sponsor  ICMJE Bioness Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Keith McBride Bioness Inc
Principal Investigator: Howard Goldman, MD The Cleveland Clinic
Study Director: Charlene Myers Bioness Inc
PRS Account Bioness Inc
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP