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

NCT02873312 | Unknown FDA Device

• 1 other identifier: CP-STMR-OAB-002
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 19

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. 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. 2.To assess safety of the StimRouter therapy for the indication of OAB

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 1) Patient Voiding Diary

  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

  Occurrence of anticipated and unanticipated adverse events will be documented, accumulated and reported for the duration of the study

  Baseline through Month 6

Secondary Outcomes (1)

• Seven-Day Patient Voiding Diary

  Baseline, Month 3

Study Arms (2)

StimRouter Treatment

EXPERIMENTAL

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

StimRouter Control

SHAM COMPARATOR

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

Interventions

StimRouter DEVICE

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.

Also known as: StimRouter Neuromodulation System

StimRouter Control; StimRouter Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Neurogenic bladder
• Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH), treated or untreated, with ongoing significant obstruction
• Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
• Urinary tract, bladder or vaginal infection or inflammation
• More than minimal level of stress incontinence or mixed incontinence with stress component likely to confound study outcome
• Type I diabetes or uncontrolled Type II diabetes
• Allergy to local anesthetic or adhesives
• Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the implant
• 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
• Skin lesions or compromised skin at the implant or stimulation site
• Use of investigational drug or device therapy or participation in any study involving or impacting gynecologic, urinary or renal function within past 4 weeks
• Implanted neurostimulator, pacemaker, or defibrillator
• Current use of TENS in pelvic region, back or leg
• Current or prior use of electrical stimulation therapy for OAB (e.g. PTNS, sacral nerve stimulation, pelvic floor muscle stimulation or biofeedback)
• Metallic implant below knee, within 6 inches of proposed site for implanted lead

Sponsors & Collaborators

• Bioness Inc: lead

Study Sites (19)

Del Sol Research

Tucson, Arizona, 85710, United States

WITHDRAWN

Kaiser Permanente Reserach

Irvine, California, 92618, United States

RECRUITING

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

Providence St. John's Health Center

Santa Monica, California, 90404, United States

RECRUITING

Skyline Urology

Sherman Oaks, California, 91411, United States

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

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

RECRUITING

Basel Hassoun

Oklahoma City, Oklahoma, 73120, United States

COMPLETED

Michael England, MD, Texas Health Care

Fort Worth, Texas, 76104, United States

WITHDRAWN

Michael DeBakey VA Med Ctr

Houston, Texas, 77030, United States

WITHDRAWN

Northern Alberta Urology Center

Edmonton, Alberta, T6G1Z1, Canada

RECRUITING

Silverado Research, Inc

Victoria, British Columbia, V8T2C1, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T258, Canada

RECRUITING

University of Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith McBride

  Bioness Inc

  STUDY CHAIR

• Howard Goldman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Madrid, CRA

CONTACT

6617144595; cathy.madrid@bioness.com

Keith McBride

CONTACT

(661) 362-4866; keith.mcbride@bioness.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 19, 2016
• Study Start: February 10, 2017
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: January 29, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); US (15)