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

NCT ID: NCT07247136

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-19
• Study Completion Date: 2026-11-30

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.

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 20 subjects will be implanted.

Conditions

Urinary Urge Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuspera Implantable Sacral Nerve Stimulation System

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

Group Type: OTHER

Neuspera Implantable Sacral Neuromodulation System

Intervention Type: DEVICE

Stimulation of the Sacral Nerve

Interventions

Neuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuspera Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Reub, MD

Role: PRINCIPAL_INVESTIGATOR

Southern Urogynecology

Locations

Southern Urogynecology, LLC

West Columbia, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark Vollmer

Role: CONTACT

mark.vollmer@neuspera.com

408-433-3839

Shital Patel

Role: CONTACT

shital.patel@neuspera.com

323-528-1320

Facility Contacts

Jessica Rueb, MD

Role: primary

803-457-7000 ext. 6

Tina McGready

Role: backup

tmcgready@southurogyn.com

803-457-7000 ext. 6

Related Links

http://neuspera.com

Neuspera Medical web page

Other Identifiers

Neuspera Medical (NSM-006)

Identifier Type: -

Identifier Source: org_study_id