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.
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 20 subjects will be implanted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Stimulation of the Sacral Nerve
Southern Urogynecology, LLC
West Columbia, South Carolina, United States
RECRUITINGPrimary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs
Proportion of Subjects experiencing a device- and/or procedure-related Adverse events
Time frame: 6 months
Primary Effectiveness Endpoint-Percentage of all implanted subjects who experience an improvement in UUI episodes.
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more, relative to the number of UUI episodes at baseline.
Time frame: 1, 3 and 6 months post implant
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