N/A Completed N=10 Device Feasibility

Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Source: ClinicalTrials.gov NCT04115228 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcomePrimary: Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks — -89 percent change

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks	-89	—
PRIMARY Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks	-90	—
PRIMARY Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks	-30	—
PRIMARY Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks	-69	—
SECONDARY Threshold at 13 Weeks	1.03	—
SECONDARY Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks	-40	—
SECONDARY Score on a Global Response Assessment (GRA) Scale at 13 Weeks	5.8	—

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) 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04115228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.