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)

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Urge Incontinence
• Intervention / Treatment: Device: Neuspera Implantable Sacral Neuromodulation 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Vollmer; Phone Number: 408-433-3839; Email: mark.vollmer@neuspera.com
• Study Contact Backup: Name: Shital Patel; Phone Number: 323-528-1320; Email: shital.patel@neuspera.com

Study Locations

• United States
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Recruiting
      • Southern Urogynecology, LLC
      • Contact: Jessica Rueb, MD; Phone Number: 6 803-457-7000
      • Contact: Tina McGready; Phone Number: 6 803-457-7000; Email: tmcgready@southurogyn.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• 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®).
• Is a woman who is pregnant or planning to become pregnant during this clinical study or is a woman of child-bearing potential who is not using a medically acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with clear negative result.
• Has previously had SNM therapy.
• Has active implantable medical devices such as neurostimulators, drug pumps, pacemakers, or internal defibrillators since compatibility has not been assessed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Neuspera Implantable Sacral Nerve Stimulation System; Implantation of the stimulator to assess effectiveness with shorter duration of stimulation	Device: Neuspera Implantable Sacral Neuromodulation System; Stimulation of the Sacral Nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Neuspera Medical, Inc.
• Investigators: Principal Investigator: Jessica Reub, MD, Southern Urogynecology

Publications and helpful links

Helpful Links

• Neuspera Medical web page

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Urge
• Other Study ID Numbers: Neuspera Medical (NSM-006)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes