Clinical trial NCT05250908: INTIBIA Pivotal Study
Official title: A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence, Urge
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 208
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response Rate
timeFrame: 3 Months
measure: Response Rate
timeFrame: 12 Months
Secondary outcomes:
measure: Urgency Score
timeFrame: 3 Months
measure: Daily Voids
timeFrame: 3 Months
Other outcomes:
measure: Response Rate
timeFrame: 6 Months
measure: Response Rate
timeFrame: 3, 6, and 12 Months
measure: Daily Voids
timeFrame: 6 and 12 Months
measure: Urgency Score
timeFrame: 6 and 12 Months
measure: International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
timeFrame: 3, 6, and 12 Months
measure: OverActive Bladder questionnaire - Short Form
timeFrame: 3, 6, and 12 Months
measure: Dry
timeFrame: 3, 6, and 12 Months
measure: Patient's Global Impression of Improvement Questionnaire
timeFrame: 3, 6, and 12 Months
measure: Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 3 Months
measure: EQ-5D-5L Questionnaire
timeFrame: 3, 6, and 12 Months
Locations:
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Group
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Advanced Urology Associates
state: Florida
city: Moultrie
country: United States
facility: Southeastern Urogynecology & Pelvic Surgery
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark WomenCare Specialists
state: Idaho
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC
state: Kansas
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan
state: Michigan
city: St. Louis
country: United States
facility: Specialty Clinical Research of St. Louis
state: Missouri
city: Denville
country: United States
facility: Atlantic Health System - AMG Urology (Garden State Urology)
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health
state: Pennsylvania
city: Bala Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Newtown
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Amsterdam
country: Netherlands
facility: Bergman Clinics, Women's Health, Department of Gynecology
city: Zwolle
country: Netherlands
facility: Isala Zwolle
Study officials:
affiliation: Wake Forest University
name: Catherine Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: