Overactive Bladder Clinical Trial in Las Vegas NV
NCT02873312
| Interventional
This study is looking to recruit 180 Participants
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.
Details for the study
Brief Title
Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial
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)
Brief Summary
Approximately 20 Study Sites will participate over total 24 months. Study population will
<br /> consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3
<br /> months.
<br />
<br /> Primary Study Objectives:
<br />
<br /> 1. To assess efficacy of the StimRouter stimulation in improving OAB symptoms of urgency
<br /> and frequency as measured by Patient Voiding Diary when targeting the posterior tibial
<br /> nerve
<br />
<br /> 2. To assess safety of the StimRouter therapy for the indication of OAB
<br />
<br /> Secondary Study Objective:
<br />
<br /> To evaluate efficacy of the StimRouter therapy in addressing urinary urge incontinence as
<br /> measured by the Patient Voiding Diary
<br />
<br /> Study Design is prospective, multi-center, randomized, double-blinded
<br />
<br /> Primary Endpoint:
<br />
<br /> The primary efficacy endpoint will be the difference between the investigational and control
<br /> groups in proportion of responders, where Responder is defined as having ≥50% improvement in
<br /> average voiding frequency above the normal value of 8 (those returning to normal voiding
<br /> based on 7-day average voids/leak episodes < 9, will be categorized as achieving half or more
<br /> reduction) AND having ≥50% improvement in average number of moderate to severe urgency
<br /> episodes, at approximately three months after programming.
<br />
<br /> Secondary Endpoint:
<br />
<br /> Secondary endpoint will be the difference between the investigational and control groups in
<br /> proportion of patients with reduction by half or more in urinary urge incontinence as
<br /> 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.
Treatments and/or Procedures
Stim router
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
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
Primary
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.
Secondary
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.
Study 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. 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