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

Recruiting

• Conditions: Urgency Urinary Incontinence (UUI); urine loss; 10046590

• Registration Number: NL-OMON56302
• Lead Sponsor: Coloplast Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Women or men 22-80 years of age
2. 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
3. Greater than or equal to 6-month history of UUI diagnosis
4. Failure of conservative or behavioral therapy (e.g., bladder diet, timed
voiding, bladder training, bladder control strategies, pelvic floor muscle
training, fluid management)
5. Willing to abstain from OAB medications for the duration of the study
6. 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
7. Ambulatory and able to use the toilet independently and without difficulty
8. Willing and capable of providing informed consent
9. Willing and able to complete all procedures and follow-up visits indicated
in the protocol

Exclusion Criteria

1. 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
2. Current symptomatic urinary tract infection (UTI), urethritis, or more than
three (3) UTIs in past year
3. Have post-void residual urine volume >30% of total voided volume
4. Inadequate skin integrity or any evidence of an infection, edema or
inflammation in either lower leg
5. Evidence of anatomic abnormalities that could jeopardize the placement of
the device or pose a hazard to the subject
6. Prior treatment of urinary symptoms with nerve stimulation (e.g.,
percutaneous tibial nerve stimulation [PTNS] or sacral nerve stimulation [SNS])
7. History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme
disease, chronic back pain)
8. An active implantable electronic device regardless of whether stimulation is
ON or OFF
9. Treatment of urinary symptoms with botulinum toxin therapy within twelve
(12) months
10.
Anyneurologicalconditionthatcouldinterferewithnormalbladderortibialnervefunction
,including stroke, epilepsy, multiple sclerosis, Parkinson*s disease,
peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia)
11. Current urinary tract mechanical obstruction (e.g.,benign prostatic
enlargement or urethral stricture)
12. Other urinary tract dysfunction (e.g.,abnormal upper urinary tract
function, vesicoureteral reflux, bladder stone or tumor, urinary fistula)
13. Endstage renal failure,GFR<35, or dialysis
14. History of pelvic cancer within the past two years
15. Pelvic organ prolapse at or beyond the hymenal ring
16.
InterstitialcystitisorbladderpainsyndromeasdefinedbyeitherAmericanUrologicalAsso
ciation (AUA) or European Association of Urology (EAU) guidelines prior to
INTIBIA implant date
17. Diabetes with peripheral nerve compromise or uncontrolled diabetes
18. 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
19. Current active or a chronic systemic infection
20. Condition requiring magnetic resonance imaging(MRI) of lower leg
21. Condition requiring diathermy
22. Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium,
or polyurethane
23. Allergy to local anesthetic or adhesives
24.
Deemedunsuitableforenrollmentbytheinvestigatorbasedonhistoryorphysicalexaminatio
n(e.g., bleeding disorders, current anticoagulant medications)
25. Enrolled in another investigational or interventional device or drug trial
over the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The co-primary efficacy endpoints are defined as:<br /><br><br /><br>1. The proportion of ITNS-ON subjects achieving >= 50% reduction in urgency<br /><br>urinary incontinence episodes relative to baseline versus a performance<br /><br>threshold (PT) of 50% at 12 months. The endpoint will be considered met if the<br /><br>ITNS-ON treatment group is statistically superior to the PT.<br /><br><br /><br>2. The proportion of subjects achieving a >= 50% reduction in urgency urinary<br /><br>incontinence episodes relative to baseline at 3- months. The endpoint will be<br /><br>considered met if the ITNS-ON treatment group is 1statistically superior by a<br /><br>margin of 10% to the ITNS-SHAM treatment group .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Efficacy Endpoints will be tested for superiority of the ITNS-ON<br /><br>group as compared to ITNS-SHAM group in the following order:<br /><br>• The change in mean urgency score relative to baseline at 3- months.<br /><br>• The change in mean number of daily voids relative to baseline at 3-months.</p><br>