Neuspera SNM System follow-up: comparing patient experience with traditional SNM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, single-arm study will enroll up to 20 adults with urinary urge incontinence who currently have or recently removed a traditional SNM device and are receiving the Neuspera implant. Participants complete a pre-implant questionnaire about their experience with the traditional SNM and then undergo implantation of the Neuspera device followed by a 1-month follow-up. The study uses standard-of-care implantation and aims to compare patient-reported outcomes after switching devices. Data will describe perceived changes in comfort, effectiveness, and overall satisfaction related to the Neuspera system.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year
2. Is 22 years of age or older
3. Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
4. Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
5. Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.

Exclusion Criteria:

1. Has a contraindication for the Neuspera SNM System per the device labeling.
2. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study

Where it's running

• Specialty Clinical Research of St. Louis
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Kellen Choi, DO — University of Louisville Health System
• Study coordinator: Mark Vollmer
• Email: mark.vollmer@neuspera.com
• Phone: 408-433-3839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing pain from different numbers of bladder injections of Botox

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.