Post-Approval Study of the Neuspera Sacral Neuromodulation (Snm) System in Patients with Symptoms of Urinary Urgency Incontinence (Uui)

Investigation of Sacral Neuromodulation System for Urinary Urgency Incontinence

C
Charles Powell, MD

Primary Investigator

Enrolling By Invitation
22 years - 100 years
All
Phase N/A
4 participants needed
1 Location

Brief description of study

Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System.

Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS_UUI (NSM-004) Study.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

The Neuspera SNM System received FDA PMA approval for the treatment of urinary urge incontinence in subjects who have failed, could not tolerate, or were not a candidate for more conservative treatment. The study will serve as the Post Approval Study (PAS) requirement of the PMA Approval.

This post approval study (PAS) is designed to assess the long-term safety and effectiveness data out to 72 months post-implant, in consenting subjects implanted in Phase I or Phase II study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Urinary Urgency Incontinence (Uui)
  • Age: 22 years - 100 years
  • Gender: All

Inclusion Criteria:

  • Subjects in the SANS-UUI Phase I or Phase II study

 

The purpose of this study is to investigate the long-term safety and effectiveness of an investigational sacral neuromodulation system for patients experiencing urinary urgency incontinence. Urinary urgency incontinence is a condition where there is a sudden need to urinate that is difficult to control, leading to involuntary leakage of urine.

Participants in the study will undergo procedures to evaluate the performance of the sacral neuromodulation system. This involves regular assessments to monitor the system's safety and how well it works in managing urinary urgency incontinence symptoms.

  • Who can participate: Eligibility criteria are not detailed in the provided information.
  • Study details: Participants will be required to attend assessments to monitor the system's safety and effectiveness.
Updated on 16 Oct 2025. Study ID: UROL-NEUSPERA-NSM-005, 28601
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only