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Sacral Nerve Stimulation for Urinary Incontinence
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Neuspera Implantable Sacral Nerve Stimulation System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many healthcare centers are participating in this experimentation?
"The current cohort of this medical trial is enrolling patients at 10 distinct sites, which includes Austin, Los Angeles and Dallas in addition to other locations. To minimise the burden of travel, it's beneficial to enrol at a clinic closest to you."
What overarching objective is this clinical trial aiming to fulfill?
"This six-month clinical trial is assessing the efficacy of a new medication, which will be measured by calculating the proportion of participants with at least 50% reduction in Urinary Urgency Incontinence episodes. Additionally, patient and physician satisfaction via five-point scale questionnaires as well as changes in urinary frequency from baseline to follow-up are being monitored as secondary objectives."
Is enrollment for this clinical experiment still open?
"According to clinicaltrials.gov, the advertised study is now open for enrollment. It was originally posted in December of 2019 and has been recently updated on June 24th 2022."
What is the current capacity of participants for this experimental protocol?
"Affirmative. Clinicaltrials.gov documents that this medical trial, initially posted on December 13th 2020 and recently revised on June 24 2022, is actively seeking enrolment of 310 participants at 10 different clinical sites."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Most responsive sites:
- MetroHealth: < 48 hours
Average response time
- < 2 Days
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