INTIBIA Pivotal Study
Purpose
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).
Conditions
- Urinary Incontinence, Urge
- Urinary Bladder, Overactive
- Urinary Bladder Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
Eligibility
- Eligible Ages
- Between 22 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Subjects and investigator/site personnel are blinded until the Month 3 visit.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental INTIBIA Therapeutic |
Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study. |
|
|
Experimental 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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Coloplast A/S
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.