Actively Recruiting
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
Led by Neuspera Medical, Inc. · Updated on 2026-03-05
30
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 22 years or older
- Diagnosed with urinary urge incontinence for at least 6 months before screening
- Failed, could not tolerate, or not a good candidate for at least one antimuscarinic or β3 adrenoceptor agonist medication
- Willing and able to stop overactive bladder medications for a suitable washout period before baseline or maintain medication during the study
- Has at least 4 UUI episodes on a 72-hour diary
- Positive response to stimulation trial with at least 50% reduction in UUI episodes
You will not qualify if you...
- Contraindications for the Neuspera SNM System as per device labeling
- Hemoglobin A1c greater than 8%
- Presence of glucosuria
- Diagnosed diabetic neuropathy
- Interstitial cystitis, bladder pain syndrome, chronic pelvic pain, or recurrent urinary tract infections
- Skin, orthopedic, neurological, hematological, or anatomical issues preventing neurostimulator placement
- Broken or blistered skin or poor circulation at implant site
- Neurogenic bladder dysfunction or history of related neurological disorders
- Documented urinary retention within 6 months before screening
- Clinically significant bladder outlet obstruction
- Current or past pelvic irradiation
- Mechanical obstruction such as benign prostatic hypertrophy, urethral stricture, or cancer
- Grade 3 or 4 pelvic organ prolapse
- Received tibial nerve stimulation in past 3 months or unwilling to avoid it during study
- Received botulinum neurotoxin treatment for urinary symptoms in past 6 months
- Pregnant or not using acceptable birth control if of child-bearing potential
- Previous sacral neuromodulation therapy
- Active implantable medical devices like neurostimulators, drug pumps, pacemakers, or internal defibrillators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Southern Urogynecology, LLC
West Columbia, South Carolina, United States, 29169
Actively Recruiting
Research Team
M
Mark Vollmer
CONTACT
S
Shital Patel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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