Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

NCT ID: NCT04115228

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2021-03-03

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Study device

Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.

Group Type: EXPERIMENTAL

Implantation and neuromodulation therapy

Intervention Type: DEVICE

The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.

Interventions

Implantation and neuromodulation therapy

The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.

Intervention Type: DEVICE

Other Intervention Names

Nine Continents Medical ITNS model 9C-680

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Nine Continents Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parminder Sethi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pacific Urology

Locations

Pacific Urology

San Ramon, California, United States

Countries

United States

References

Sethi PS, Peters KM. A First-In-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome. Neuromodulation. 2025 Jul;28(5):832-839. doi: 10.1016/j.neurom.2025.01.013. Epub 2025 Mar 1.

Reference Type: DERIVED

PMID: 40029222 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R44DK121578

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ITNS-01

Identifier Type: -

Identifier Source: org_study_id