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



Status:Recruiting
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:22 - Any
Updated:1/18/2019
Start Date:February 10, 2017
End Date:December 31, 2019
Contact:Keith McBride
Email:keith.mcbride@bioness.com
Phone:(661) 362-4866

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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:

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.

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.

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
We found this trial at
16
sites
Las Vegas, Nevada 89109
Phone: 701-732-0282
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: David Ginsberg, MD
Phone: 323-865-0702
University of Southern California The University of Southern California is one of the world’s leading...
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22285 North Pepper Road
Barrington, Illinois 60010
Phone: 847-852-4306
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101 Manning Drive
Chapel Hill, North Carolina 27514
Principal Investigator: Elizabeth Geller, MD
Phone: 919-843-8259
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2050 East 96th Street
Cleveland, Ohio 44195
Phone: 216-444-1152
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11400 University Avenue
Edmonton, Alberta T6G 1Z1
Principal Investigator: Gary Gray, MD
Phone: 780-425-5598
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799 East Hampden Avenue
Englewood, Colorado 80113
Phone: 303-733-8848
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1250 8th Avenue
Fort Worth, Texas 76104
Phone: 817-923-5559
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Houston, Texas 77030
Principal Investigator: Christopher P Smith, MD
Phone: 713-798-8106
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Irvine, California 92618
Principal Investigator: Emily Whitcomb, MD
Phone: 626-564-3731
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4200 West Memorial Road
Oklahoma City, Oklahoma 73120
Phone: 405-749-9889
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Pompano Beach, Florida 33060
Principal Investigator: Steven Kester, MD
Phone: 954-946-8873
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Santa Monica, California 90404
Principal Investigator: Achal Achrol, MD
Phone: 310-582-7003
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310 Eisenhower Drive
Savannah, Georgia 31405
Principal Investigator: Buffi G Boyd, MD
Phone: 912-443-4253
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Sherman Oaks, California 91411
Principal Investigator: Richard David, MD
Phone: 323-803-3611
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850 North Kolb Road
Tucson, Arizona 85710
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