Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
- Conditions
- Urinary Urgency Incontinence
- Registration Number
- NCT04232696
- Lead Sponsor
- Neuspera Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 242
Inclusion Criteria:<br><br> 1. Has a Body Mass Index (BMI) between 18 and 40.<br><br> 2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening<br> baseline visit date.<br><br> 3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor<br> training, biofeedback, behavioral modification).<br><br> 4. Has failed or could not tolerate (stopped taking medication due to lack of efficacy<br> or intolerable side effects) or not a good candidate for (as determined by treating<br> physician) at least one (1) antimuscarinic or ß3 adrenoceptor agonist medication.<br><br> 5. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum<br> of one (1) UUI episode per 24-hour period.<br><br>Exclusion Criteria:<br><br> 1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with<br> glucosuria.<br><br> 2. Has diabetic neuropathy.<br><br> 3. Has interstitial cystitis or bladder pain syndrome as defined by either American<br> Urological Association (AUA) or European Association of Urology (EAU) guidelines,<br> chronic pelvic pain or recurrent symptomatic urinary tract infections.<br><br> 4. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy,<br> multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.<br><br> 5. Has documented urinary retention within 6 months prior to the screening baseline<br> visit date.<br><br> 6. Has clinically significant bladder outlet obstruction.<br><br> 7. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy,<br> urethral stricture or cancer.<br><br> 8. Has primary stress incontinence or mixed incontinence where the stress component<br> predominates or has been treated surgically for stress urinary incontinence within 6<br> months prior to the screening baseline visit date.<br><br> 9. Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment<br> of overactive bladder or unwilling to stay off TNS therapy for 12-month period<br> following implant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II Primary Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence episodes.;Phase II Primary Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up.
- Secondary Outcome Measures
Name Time Method Phase II Change in Quality of Life: Measured from baseline as measured and assessed by the total and subset International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life score.;Phase II Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence.;Phase II Urgent Voids per Day;Phase !! Change in Average Number of Daily Voids;Phase II Comprehensive Summary of all Adverse Events;Phase II Device Parameter Information Collected;Phase II Physician and Subject User Experience Questionnaire;Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules;Phase II Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up.;Phase II Urinary Output;Phase II Fecal Incontinence Measured by Wexner Scale;Phase II Patient Global Impression of Improvement