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Device
Sacral Nerve Stimulation for Urinary Incontinence
N/A
Waitlist Available
Research Sponsored by Neuspera Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period.
Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
Study Summary
This trial is to study a new system for treating urinary incontinence that has failed or could not tolerate more conservative treatment. The trial will be conducted in two phases. Phase I is to assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial. Phase II is to assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.
Who is the study for?
This trial is for individuals with Urinary Urgency Incontinence (UUI) who haven't had success with or can't handle standard treatments. Participants should have a BMI between 18 and 40, have struggled with UUI for at least 6 months, and experience frequent UUI episodes. People are excluded if they have certain conditions like uncontrolled diabetes, urinary retention history, bladder obstructions, or specific neurological disorders.Check my eligibility
What is being tested?
The Neuspera Implantable Sacral Nerve Stimulation System is being tested in two phases to see how well it works and how safe it is for treating UUI. Phase I will determine the daily stimulation duration needed while Phase II will evaluate the system's effectiveness after six months and safety after twelve months.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the implant site, infection risk from surgery, nerve damage symptoms such as pain or changes in sensation, and possible malfunction of the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with urge urinary incontinence, experiencing at least 4 episodes in 3 days.
Select...
I have tried or cannot try basic treatments like pelvic exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Phase !! Change in Average Number of Daily Voids
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 Comprehensive Summary of all Adverse Events
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Neuspera Implantable Sacral Nerve Stimulation SystemExperimental Treatment1 Intervention
Implantation of the simulator.
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Who is running the clinical trial?
Neuspera Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Urinary Incontinence
6 Patients Enrolled for Urinary Incontinence
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stress incontinence or had surgery for it within the last 6 months.I have been diagnosed with urge urinary incontinence, experiencing at least 4 episodes in 3 days.I have a serious blockage in my bladder.I have not used tibial nerve stimulation for overactive bladder in the last 3 months, or I am willing to avoid it for the next 12 months.I have a blockage caused by an enlarged prostate, narrowing of the urethra, or cancer.Your weight in relation to your height is within a certain range.I have tried or cannot try basic treatments like pelvic exercises.I have chronic bladder pain or frequent urinary infections.My A1c level is above 8%, or I have diabetes with sugar in my urine.I've tried or can't take certain bladder medications due to side effects or lack of effectiveness.You have had trouble urinating and it was recorded within the last 6 months before the screening visit.I have nerve damage due to diabetes.I have been diagnosed with urgent urination issues for 6 months or more.I have bladder issues due to a nerve problem from conditions like MS or Parkinson's.
Research Study Groups:
This trial has the following groups:- Group 1: Neuspera Implantable Sacral Nerve Stimulation System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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