Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

NCT04115228 | Completed Results DMC FDA Device

• 2 other identifiers: ITNS-01R44DK121578
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Percent Change of Urinary Incontinence Frequency From 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.

  Baseline to 13 weeks

• Percent Change of Excess Voiding Frequency During Waking Hours From 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.

  Baseline to 13 weeks

• Percent Change of Frequency of Voids Awakening From Sleep From 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.

  Baseline to 13 weeks

• Percent Change of Frequency of Voids With Urgency From 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

  Baseline to 13 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Study device

EXPERIMENTAL

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.

Device: Implantation and neuromodulation therapy

Interventions

Implantation and neuromodulation therapy 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.

Also known as: Nine Continents Medical ITNS model 9C-680

Study device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nine Continents Medical, Inc.: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Pacific Urology

San Ramon, California, 94583, United States

Location

Related Publications (1)

• 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.

  PMID: 40029222 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Clinical feasibility study with single-arm design, single investigator, and small sample size.

Results Point of Contact

• Title: Peter Jacobson
• Organization: Nine Continents Medical, Inc.

PETERJACOBSON777@YAHOO.COM

6128105810

Study Officials

• Parminder Sethi, M.D.

  Pacific Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: October 9, 2019
• Primary Completion: January 31, 2021
• Study Completion: March 3, 2021
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)