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Device

Sacral Nerve Stimulation for Urinary Incontinence

N/A
Recruiting
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 below
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I have been diagnosed with urge urinary incontinence, experiencing at least 4 episodes in 3 days.
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I have tried or cannot try basic treatments like pelvic exercises.
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I've tried or can't take certain bladder medications due to side effects or lack of effectiveness.
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I have been diagnosed with urgent urination issues for 6 months or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

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 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neuspera Implantable Sacral Nerve Stimulation SystemExperimental Treatment1 Intervention
Implantation of the simulator.

Find a Location

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

Neuspera Implantable Sacral Nerve Stimulation System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04232696 — N/A
Urinary Incontinence Research Study Groups: Neuspera Implantable Sacral Nerve Stimulation System
Urinary Incontinence Clinical Trial 2023: Neuspera Implantable Sacral Nerve Stimulation System Highlights & Side Effects. Trial Name: NCT04232696 — N/A
Neuspera Implantable Sacral Nerve Stimulation System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04232696 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
MetroHealth
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. MetroHealth: < 48 hours
Average response time
  • < 2 Days
~59 spots leftby Mar 2025