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Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System | Clinical Trials | Clareo Health

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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)

NCT07247136•Neuspera Medical, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is male or female 22 years of age or older.
•Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
•Has failed, could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
•Is willing and able to washout (at least five half-lives) from OAB medications for a period determined appropriate based on type of OAB medication prior to the baseline bladder diary and remain off OAB medications through the study duration OR must be willing to maintain medication through the study duration.
•Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary.
•Has a positive stimulation trial with a 50% reduction in UUI episodes.

Exclusion Criteria

•Has a contraindication for the Neuspera SNM System per the device labeling.
•Has a hemoglobin A1c of \>8%.
•Has glucosuria.
•Has diabetic neuropathy.
•Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain, or recurrent symptomatic urinary tract infections.
•Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator.
•Has broken, blistered skin or compromised circulation in the area of the neurostimulator implant.
•Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
•Has documented urinary retention within 6 months prior to the screening baseline visit date.
•Has clinically significant bladder outlet obstruction.
+8 more criteria

Locations (1)

Southern Urogynecology, LLC

West Columbia, South Carolina, United States

Key Dates

Start Date

November 19, 2025

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Urinary Urge Incontinence

Interventions

Neuspera Implantable Sacral Neuromodulation System

DEVICE

Contacts

Mark Vollmer

CONTACT

408-433-3839 mark.vollmer@neuspera.com

Shital Patel

CONTACT

323-528-1320 shital.patel@neuspera.com

F15 Recharge Free Axonics SNM System Clinical Study

NCT06186765

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COMPLETED

Bladder Diary for Female Storage LUTS

NCT06222515

Urinary Urge IncontinenceUrinary Frequency More Than Once at Night+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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