Overactive BladderNCT02873312
Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial
A study testing StimRouter in people with Overactive Bladder, run by Bioness Inc at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- StimRouter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 10 Feb 2017to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- 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
- 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
- Requirement for serial MRIs
- Presence of a documented condition or abnormality that could compromise the safety of the patient
- Life expectancy of less than 1 year
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites, 6 recruiting
- Completed
Comprehensive Urologic Care
Barrington, Illinois, 60010
- Completed
University of North Carolina Urogynecology
Chapel Hill, North Carolina, 27514
- Recruiting
Cleveland Clinic Glickman Urologic and Kidney Institute
Cleveland, Ohio, 44195
Andrea Aaby, 216-444-1152, aabya@ccf.org
Kathleen Dolphin, PA, 216-245-5121, DOLPHIK@ccf.org
- Completed
Barrett Cowan, MD, Urology Associates
Englewood, Colorado, 80113
- Withdrawn
Michael England, MD, Texas Health Care
Fort Worth, Texas, 76104
- Withdrawn
Michael DeBakey VA Med Ctr
Houston, Texas, 77030
- Recruiting
Kaiser Permanente Reserach
Irvine, California, 92618
Tiffany Castanon, 626-564-3731 ext. 338, Tiffany.L.Castanon@kp.org
Emily Whitcomb, MD
- Completed
Sheldon Freedman, MD LTD
Las Vegas, Nevada, 89144
- Recruiting
University of Southern California
Los Angeles, California, 90089
Ileana Aldana, MPH, 323-865-0702, Ileana.Aldana@med.usc.edu
David Ginsberg, MD
- Completed
Basel Hassoun
Oklahoma City, Oklahoma, 73120
- Completed
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
- Recruiting
Providence St. John's Health Center
Santa Monica, California, 90404
Richard A. Bailey, M.H.S., 310-829-8808, baileyr@jwci.org
Elena Berezhnikh, 310-582-7003, BerezhnikhE@jwci.org
- Recruiting
Meridian Clinical Research, LLC/Urology Associates Savannah
Savannah, Georgia, 31405
Taryn Collett, 912-443-4253, tcollett@mcrmed.com
Buffi G Boyd, MD
- Recruiting
Skyline Urology
Sherman Oaks, California, 91411
lauren david, 818-990-5020, lauren.david@skyuro.com
Alicia Buenrostro, 8189905020, alicia.buenrostro@skyuro.com
- Withdrawn
Del Sol Research
Tucson, Arizona, 85710
Canada4 sites, 4 recruiting
- Recruiting
Northern Alberta Urology Center
Edmonton, Alberta, T6G1Z1
Donna Moskalyk, RN, 780-425-5598, donna.moskalyk@albertahealthservices.ca
Gary Gray, MD
- Recruiting
University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Elsie Morneau, BSN, 819-346-1110 ext. 12827, elsie.morneau.ciussse-chus@ssss.gouv.qc.ca
Le Mai Tu, MD
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T258
Rowaa Banjar, MD, 416-603-5018, Rowaa.Banjar@uhn.ca
Dean Elterman, MD, 416-603-5800, dean.elterman@uhn.ca
- Recruiting
Silverado Research, Inc
Victoria, British Columbia, V8T2C1
Amanda Pawlowski, 250-592-9998, amanda@silveradoresearch.org
Grace Wicken, 250-592-9998, admin@silveradoresearch.org
About this study
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)
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:
Read more
- 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
- 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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- StimRouter
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimRouterDevice
Also called StimRouter Neuromodulation System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: StimRouter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline through Month 6
Secondary outcomes (1)
Seven-Day Patient Voiding Diary
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.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start10 Feb 2017
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioness Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith McBride, Study chair, Bioness IncHoward Goldman, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873312
- Sponsor's protocol ID
- CP-STMR-OAB-002
- Status last verified
- Jul 2020
- First submitted
- 10 Aug 2016
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02873312
- Acronym / sponsor ID
- CP-STMR-OAB-002
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Bioness IncIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StimRouter Treatment | Experimental | Device: StimRouterThe 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. |
| StimRouter Control | Sham comparator | Device: StimRouterThe 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimRouterAlso: StimRouter Neuromodulation SystemThe 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. | Device | StimRouter Control, StimRouter Treatment |
Primary outcome
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
1 secondary outcome
Seven-Day Patient Voiding Diary
Time frame: Baseline, Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith McBride study chair
Bioness Inc
Howard Goldman, MD principal investigator
The Cleveland Clinic
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimRouter in people with Overactive Bladder, run by Bioness Inc at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy Madrid, CRA (6617144595, cathy.madrid@bioness.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Patient Voiding Diary (time frame: Baseline, Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.