Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Nine Continents Medical, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Study objectives: To report feasibility data for safety and effectiveness of the study device.
Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Type of design: Single-arm longitudinal design.
Study sites: Single site, in the United States.
Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At pre-screening:
- •Age 18 years or older;
- •Documented diagnosis of overactive bladder;
- •Documented failed behavioral intervention and/or physical therapy;
- •Documented failed first drug for overactive bladder; and
- •Documented failed second drug for overactive bladder.
- •At screening:
- •Life expectancy of at least one year;
- •Capable of tolerating the implantation procedure;
- •Ambulatory and able to use the toilet independently and without difficulty; and
Exclusion Criteria
- •At pre-screening:
- •Predominant stress incontinence;
- •For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II;
- •Neurologic disease, e.g. MS, Parkinson's;
- •Abnormal upper urinary tract function;
- •Neurogenic bladder;
- •Bladder stone or tumor;
- •Body mass index (BMI) \> 40;
- •Chronic pelvic pain;
- •Urinary fistula;
Outcomes
Primary Outcomes
Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks
Time Frame: Baseline to 13 weeks
For a participant analyzed, let x0 = average number of voids with leakage per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with leakage per 24 hours in first 72 hours of 13-week diary, and x = percent change of urinary incontinence frequency from baseline to 13 weeks. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 4 voids with leakage per 24 hours in the first 72 hours of the baseline diary and 2 voids with leakage per 24 hours in the first 72 hours of the 13-week diary would have a percent change of urinary incontinence frequency from baseline to 13 weeks of 100 \* (2 - 4) / 4 = -50.
Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks
Time Frame: Baseline to 13 weeks
For a participant analyzed, let x0 = average number of voids with urgency per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with urgency per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids with urgency from baseline to 13 weeks, where "voids with urgency" means voids self-reported with some or severe urgency, or leakage. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 8 voids with urgency per 24 hours in the first 72 hours of the baseline diary and an average of 5 voids with urgency per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids with urgency from baseline to 13 weeks of 100 \* (5 - 8) / 8 = -37.5
Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks
Time Frame: Baseline to 13 weeks
For a participant analyzed, let x0 = average number of voids during waking hours per 24 hours in first 72 hours of baseline diary, x1 = average number of voids during waking hours per 24 hours in first 72 hours of 13-week diary, and x = percent change of excess voiding frequency during waking hours from baseline to 13 weeks, where "excess" means voids during waking hours exceeding 7 per 24 hours. Then x = 100 \* (x1 - x0) / (x0 - 7). For example, a participant with an average of 16 voids during waking hours per 24 hours in the first 72 hours of the baseline diary and an average of 10 voids during waking hours per 24 hours during the first 72 hours of the 13-week diary would have a percent change of excess voiding frequency during waking hours from baseline to 13 weeks of 100 \* (10 - 16) / (16 - 7) = -67.
Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks
Time Frame: Baseline to 13 weeks
For a participant analyzed, let x0 = average number of voids awakening from sleep per 24 hours in first 72 hours of baseline diary, x1 = average number of voids awakening from sleep per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids awakening from sleep from baseline to 13 weeks. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 2 voids awakening from sleep per 24 hours in the first 72 hours of the baseline diary and an average of 1 void awakening from sleep per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids awakening from sleep from baseline to 13 weeks of 100 \* (1 - 2) / 2 = -50.
Secondary Outcomes
- Threshold at 13 Weeks(13 weeks)
- Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks(Baseline to 13 weeks)
- Score on a Global Response Assessment (GRA) Scale at 13 Weeks(13 weeks)