NCT07247136

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

Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Neuspera Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study is intended to investigate the potential for controlling UUI symptoms with thirty minutes of stimulation per day. Subjects will be enrolled in a single-arm study and followed for 6 months post implant. Subjects will undergo a trial stimulation period, followed by a permanent implant. If subjects do not receive appropriate benefits with the shorter duration of stimulation, they can increase the duration of stimulation anytime as needed. Subjects may also decrease stimulation after one month to 15 minutes per day if desired. Up to 30 subjects will be implanted.

Conditions

• Urinary Urge Incontinence

Interventions

Type	Name	Description
DEVICE	Neuspera Implantable Sacral Neuromodulation System	Stimulation of the Sacral Nerve

Timeline

• Start date: 2025-11-19
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-11-25
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study