INTIBIA Pivotal Study

Not Applicable

Active, not recruiting

• Conditions: Urinary Bladder Diseases; Urologic Diseases; Urinary Incontinence, Urge; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Urological Manifestations
• Interventions: Device: INTIBIA Therapeutic; Device: INTIBIA Non-Therapeutic

• Registration Number: NCT05250908
• Lead Sponsor: Coloplast A/S

Brief Summary

Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

Detailed Description

All eligible subjects will be implanted with the INTIBIA device. Subjects will be randomized to either INTIBIA therapeutic or INTIBIA non-therapeutic in a 2:1 ratio for the first 3 months of the study, at which point all subjects will receive therapeutic stimulation. Subjects will complete voiding diaries and questionnaires at Baseline and prior to each follow-up visit, which will occur at Months 3, 6, 12, and 24. Subjects will be offered to keep the device or have it explanted at the end of the study.

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-22
• Study Start: 2022-03-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-06-27
• Study Completion: 2026-06-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Women or men 22-80 years of age
• Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period
• Greater than or equal to 6-month history of UUI diagnosis
• Failure of conservative or behavioral therapy (e.g., bladder diet, timed voiding, bladder training, bladder control strategies, pelvic floor muscle training, fluid management)
• Willing to abstain from OAB medications for the duration of the study
• Willing to maintain a stable dose of all other medications that affect bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks prior to beginning the baseline voiding diary and baseline questionnaires
• Ambulatory and able to use the toilet independently and without difficulty
• Willing and capable of providing informed consent
• Willing and able to complete all procedures and follow-up visits indicated in the protocol

Exclusion Criteria

• Diagnosis of stress urinary incontinence or mixed urinary incontinence, as confirmed by cough stress test and with a response of Yes to Q3 on the UDI-6 questionnaire
• Current symptomatic urinary tract infection (UTI), urethritis, or more than three (3) UTIs in past year
• Have post-void residual urine volume >30% of total voided volume
• Inadequate skin integrity, any evidence of an infection, or lower leg edema limiting placement of device per physician discretion
• Evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject
• Prior treatment of urinary symptoms with nerve stimulation (e.g., percutaneous tibial nerve stimulation [PTNS] or sacral nerve stimulation [SNS])
• History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme disease, chronic back pain)
• An active implantable electronic device regardless of whether stimulation is ON or OFF
• Treatment of urinary symptoms with botulinum toxin therapy within six (6) months
• Any neurological condition that could interfere with normal bladder or tibial nerve function, including debilitating stroke, epilepsy, multiple sclerosis, Parkinson's disease, peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia)
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
• Other urinary tract dysfunction (e.g., abnormal upper urinary tract function, vesicoureteral reflux, bladder stone or tumor, urinary fistula)
• End stage renal failure, GFR < 35, or dialysis
• History of pelvic cancer requiring radiation or chemotherapy treatment within the past two years
• Pelvic organ prolapse at or beyond the hymenal ring
• Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines prior to INTIBIA implant date
• Diabetes with peripheral nerve compromise or uncontrolled diabetes
• Pregnant as confirmed by urine or serum pregnancy test, plans to become pregnant over the study period, is less than one-year post-partum, is breast-feeding
• Current active or a chronic systemic infection
• Condition requiring magnetic resonance imaging (MRI) of lower leg
• Condition requiring diathermy
• Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium, or polyurethane
• Allergy to local anesthetic or adhesives
• Deemed unsuitable for enrollment by the investigator based on history or physical examination (e.g., bleeding disorders, current anticoagulant medications)
• Enrolled in another investigational or interventional device or drug trial over the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTIBIA Therapeutic	INTIBIA Therapeutic	Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.
INTIBIA Non-Therapeutic	INTIBIA Non-Therapeutic	Implanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.

Primary Outcome Measures

Name	Time	Method
Response Rate	12 Months	≥50% reduction in UUUI episodes in the INTIBIA therapeutic group

Secondary Outcome Measures

Name	Time	Method
Daily Voids	3 Months	Change in mean number of daily voids relative to baseline
Urgency Score	3 Months	Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)

Trial Locations

Locations (22)

Cedars-Sinai Medical Group; 🇺🇸 Beverly Hills, California, United States

Urology Group of Southern California; 🇺🇸 Los Angeles, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Advanced Urology Associates; 🇺🇸 Daytona Beach, Florida, United States

Southeastern Urogynecology & Pelvic Surgery; 🇺🇸 Moultrie, Georgia, United States

Rosemark WomenCare Specialists; 🇺🇸 Idaho Falls, Idaho, United States

Cypress Medical Research Center, LLC; 🇺🇸 Wichita, Kansas, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Advanced Urogynecology of Michigan; 🇺🇸 Dearborn, Michigan, United States

Specialty Clinical Research of St. Louis; 🇺🇸 St. Louis, Missouri, United States

Atlantic Health System - AMG Urology (Garden State Urology); 🇺🇸 Denville, New Jersey, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

The Urology Group; 🇺🇸 Cincinnati, Ohio, United States

MetroHealth System; 🇺🇸 Cleveland, Ohio, United States

The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health; 🇺🇸 Allentown, Pennsylvania, United States

MidLantic Urology; 🇺🇸 Bala Cynwyd, Pennsylvania, United States

The Female Pelvic Health Center; 🇺🇸 Newtown, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Houston Metro Urology; 🇺🇸 Houston, Texas, United States

Bergman Clinics, Women's Health, Department of Gynecology; 🇳🇱 Amsterdam, Netherlands

Isala Zwolle; 🇳🇱 Zwolle, Netherlands