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

NCT07247136 | Recruiting FDA Device

• 1 other identifier: Neuspera Medical (NSM-006)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Urge Incontinence

Outcome Measures

Primary Outcomes (2)

• Primary 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

  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.

  1, 3 and 6 months post implant

Study Arms (1)

Neuspera Implantable Sacral Nerve Stimulation System

OTHER

Implantation of the stimulator to assess effectiveness with shorter duration of stimulation

Device: Neuspera Implantable Sacral Neuromodulation System

Interventions

Neuspera Implantable Sacral Neuromodulation System DEVICE

Stimulation of the Sacral Nerve

Neuspera Implantable Sacral Nerve Stimulation System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Is currently undergoing or has previously undergone pelvic irradiation.
• Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture, or cancer.
• Has current grade 3 or 4 pelvic organ prolapse including cystocele, rectocele, enterocele, procidentia or vaginal vault prolapse.
• Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for the study duration.
• Has received treatment of urinary symptoms with any botulinum neurotoxin type-A (BoNT-A) agent in the past 6 months; (e.g. obotulinumtoxinA, Botox,® abobotulinumtoxinA, Dysport® IncobotulinumtoxinA, Xeomin®).

Sponsors & Collaborators

• Neuspera Medical, Inc.: lead

Study Sites (1)

Southern Urogynecology, LLC

West Columbia, South Carolina, 29169, United States

RECRUITING

Related Links

• Neuspera Medical web page

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Reub, MD

  Southern Urogynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Vollmer

CONTACT

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

Shital Patel

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 25, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)