Clinical trial NCT04115228: Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Official title: Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Nine Continents Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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
* 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 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;
* 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.

Primary outcomes:
measure: Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks
timeFrame: Baseline to 13 weeks
measure: Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks
timeFrame: Baseline to 13 weeks
measure: Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks
timeFrame: Baseline to 13 weeks
measure: Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks
timeFrame: Baseline to 13 weeks
Secondary outcomes:
measure: Threshold at 13 Weeks
timeFrame: 13 weeks
measure: Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks
timeFrame: Baseline to 13 weeks
measure: Score on a Global Response Assessment (GRA) Scale at 13 Weeks
timeFrame: 13 weeks
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: Pacific Urology
state: California
Study officials:
affiliation: Pacific Urology
name: Parminder Sethi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: