Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System

Part of paid clinical trials in West Columbia, South Carolina.

Sponsor
Neuspera Medical, Inc.
Study ID
NCT07247136
Status
Recruiting
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Conditions

  • Urinary Urge Incontinence

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neuspera Implantable Sacral Neuromodulation System — DEVICE
    Stimulation of the Sacral Nerve

Study Details

Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments. The objective of the study is to assess the effectiveness of 30-minutes daily therapeutic stimulation with the Neuspera System.

Key Dates

Start date
Nov 19, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Neuspera Implantable Sacral Nerve Stimulation System
    Implantation of the stimulator to assess effectiveness with shorter duration of stimulation

Primary Outcome Measure

Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southern Urogynecology, LLCWest ColumbiaSouth Carolina29169
Jessica Rueb, MD
803-457-7000
Tina McGready
[email protected]
803-457-7000

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By research site
Southern Urogynecology, LLC· West Columbia, SC

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