INTIBIA Pivotal Study

Lower Urinary Tract Symptoms Clinical Trial

Official title:

A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250908
• Other study ID #: IU024
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: March 7, 2025

Study information

• Verified date: February 2024
• Source: Coloplast A/S
• Contact: Lisa Draper
• Phone: 6123442316
• Email: usldr[@]coloplast.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: March 7, 2025
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urinary Bladder Diseases
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urologic Diseases
• Urological Manifestations

Intervention

Device:
• INTIBIA Therapeutic
INTIBIA implantable tibial nerve stimulator with therapeutic stimulation
• INTIBIA Non-Therapeutic
INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation

Locations

Country	Name	City	State
Netherlands	Bergman Clinics, Women's Health, Department of Gynecology	Amsterdam
Netherlands	Isala Zwolle	Zwolle
United States	The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Cedars-Sinai Medical Group	Beverly Hills	California
United States	Boston Urogynecology Associates, Inc	Cambridge	Massachusetts
United States	The Urology Group	Cincinnati	Ohio
United States	MetroHealth System	Cleveland	Ohio
United States	Advanced Urology Associates	Daytona Beach	Florida
United States	Advanced Urogynecology of Michigan	Dearborn	Michigan
United States	Atlantic Health System - AMG Urology (Garden State Urology)	Denville	New Jersey
United States	Houston Metro Urology	Houston	Texas
United States	Rosemark WomenCare Specialists	Idaho Falls	Idaho
United States	Urology Group of Southern California	Los Angeles	California
United States	Marshfield Clinic Health System	Marshfield	Wisconsin
United States	Southeastern Urogynecology & Pelvic Surgery	Moultrie	Georgia
United States	The Female Pelvic Health Center	Newtown	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Specialty Clinical Research of St. Louis	Saint Louis	Missouri
United States	Baystate Medical Center	Springfield	Massachusetts
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Cypress Medical Research Center, LLC	Wichita	Kansas
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response Rate	=50% reduction in UUUI episodes in the INTIBIA therapeutic group	6 Months
Other	Response Rate	=50% reduction in number of voids or a return to normal voiding frequency (< 8 voids/day)	3, 6, and 12 Months
Other	Daily Voids	Change in mean number of daily voids relative to baseline	6 and 12 Months
Other	Urgency Score	Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)	6 and 12 Months
Other	International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form	Change in ICIQ-UI SF questionnaire total score compared to baseline. Scoring 0 (best outcome) - 21 (worst outcome)	3, 6, and 12 Months
Other	OverActive Bladder questionnaire - Short Form	Change in the OABq-SF questionnaire total score compared to baseline. Scoring 1 (best) - 6 (worst) on 19 questions.	3, 6, and 12 Months
Other	Dry	The proportion of dry subjects, defined as those with 0 incontinence episodes associated with urgency as captured on the 72-hour voiding diary	3, 6, and 12 Months
Other	Patient's Global Impression of Improvement Questionnaire	The proportion of subjects reporting "much better" or "very much better" on the Patient Global Impression of Improvement (PGI-I) questionnaire	3, 6, and 12 Months
Other	Surgical Satisfaction Questionnaire (SSQ-8)	Surgical Satisfaction Questionnaire (SSQ-8)	3 Months
Other	EQ-5D-5L Questionnaire	Change in the EQ-5D-5L index score compared to baseline, on a 1-5 scale with 1 being the best outcome and 5 being the worst outcome. VAS scale measures overall health with 0 being the worst outcome and 100 being the best outcome.	3, 6, and 12 Months
Primary	Response Rate	=50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic	3 Months
Primary	Response Rate	=50% reduction in UUUI episodes in the INTIBIA therapeutic group	12 Months
Secondary	Urgency Score	Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)	3 Months
Secondary	Daily Voids	Change in mean number of daily voids relative to baseline	3 Months