Status:
COMPLETED
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Lead Sponsor:
Nine Continents Medical, Inc.
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
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 progr...
Eligibility Criteria
Inclusion
- 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
- Able to sense and tolerate posterior tibial nerve stimulation (transcutaneous test).
- Based on pre-therapy voiding diary:
- Average daily voids during waking hours ≥ 11;
- Average daily voids interrupting sleep ≥ 2.0;
- Average daily voids associated with urgency ≥ 4; or
- Average daily incontinence episodes ≥ 1.
Exclusion
- 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;
- Peripheral neuropathy;
- History of failed neuromodulation for overactive bladder;
- Uncontrolled bleeding disorder;
- End stage renal failure, glomerular filtration rate (GFR) \< 35, or dialysis;
- Untreated diabetes or A1C \> 7;
- Implanted pacemaker, defibrillator, or neurostimulator;
- History of pelvic cancer within the past two years;
- Condition requiring magnetic resonance imaging (MRI);
- Condition requiring diathermy;
- Metallic implant in planned site of study device;
- For females, pregnant;
- For females, planning to become pregnant;
- For females, given birth in the last 6 months; or
- For females, of child-bearing potential and not willing to practice a medically-approved method of birth control during the study.
- At screening:
- Anatomical restriction preventing device placement;
- Skin lesions or compromised skin at the implant site;
- For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II;
- Post-void residual \> 150 cc;
- Urinary tract mechanical obstruction due to urethral stricture;
- Urinary tract mechanical obstruction due to bladder neck contracture;
- In males, urinary tract mechanical obstruction due to benign prostatic hyperplasia (BPH);
- Vesicoureteral reflux;
- Cystoscopic abnormalities that could be malignant;
- Current cystitis;
- Current urethritis;
- Gross hematuria;
- In females, positive pregnancy test;
- Any other medical condition with potential effect on bladder function, as assessed by investigator; or
- Any other medical condition that could compromise the safety of the subject, as assessed by investigator.
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04115228
Start Date
October 9 2019
End Date
March 3 2021
Last Update
April 12 2022
Active Locations (1)
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1
Pacific Urology
San Ramon, California, United States, 94583