Recruiting

Neuspera System

Sponsor:

Neuspera Medical, Inc.

Code:

NCT07247136

Conditions

Urinary Urge Incontinence

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Neuspera Implantable Sacral Neuromodulation System

Study Details

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

Study ID

NCT07247136

Start date

Nov 19, 2025

Status verified date

Mar, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Neuspera Implantable Sacral Nerve Stimulation System

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

Interventions

Neuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve

Primary outcome measure

  • Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs [ Time Frame: 6 months ]
  • Primary Effectiveness Endpoint-Percentage of all implanted subjects who experience an improvement in UUI episodes. [ Time Frame: 1, 3 and 6 months post implant ]

Central Contacts and Locations

Central contacts

Mark Vollmer

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

Shital Patel

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

Locations

Southern Urogynecology, LLC

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Jessica Rueb, MD

803-457-7000

Tina McGready

803-457-7000tmcgready@southurogyn.com

More Information

Sponsor

Neuspera Medical, Inc.

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuspera Medical, Inc. on 2026-03-05.