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New implant could help control bladder leaks without daily pills

NCT ID NCT04232696

Disease control Sponsor: Neuspera Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small, implantable device that stimulates the sacral nerve to help control urinary urgency incontinence (sudden, strong urges to urinate that lead to leaks). The trial involves 331 adults who have not found relief from other treatments like pelvic floor therapy or medication. The device is implanted and then adjusted to find the best stimulation settings, with the goal of reducing leakage episodes by at least 50% and improving quality of life over 6 to 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

331 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has a Body Mass Index (BMI) between 18 and 40. 2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date. 3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification). 4. Has failed or 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. 5. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period. Exclusion Criteria: 1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria. 2. Has diabetic neuropathy. 3. 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. 4. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident. 5. Has documented urinary retention within 6 months prior to the screening baseline visit date. 6. Has clinically significant bladder outlet obstruction. 7. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture or cancer. 8. Has primary stress incontinence or mixed incontinence where the stress component predominates or has been treated surgically for stress urinary incontinence within 6 months prior to the screening baseline visit date. 9. 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 12-month period following implant.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary urgency incontinence

Contacts and locations

Locations

  • Adult & Pediatric Urology P.C.

    Omaha, Nebraska, 68114, United States

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210, United States

  • Center for Pelvic Health

    Franklin, Tennessee, 37067, United States

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060, United States

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010, United States

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Florida Urology Partners, LLC

    Tampa, Florida, 33615, United States

  • Genesis Healthcare Partners

    Encinitas, California, 92024, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Kaiser Permanente

    San Diego, California, 92119, United States

  • Kaiser Permanente, LAMC

    Los Angeles, California, 90027, United States

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • Meridian Clinical Research

    Savannah, Georgia, 31406, United States

  • MetroHealth

    Cleveland, Ohio, 44109, United States

  • Midtown Urology

    Atlanta, Georgia, 95816, United States

  • Minnesota Urology

    Woodbury, Minnesota, 55125, United States

  • Ochsner Medical

    New Orleans, Louisiana, 70121, United States

  • Premier Medical Group

    Poughkeepsie, New York, 12603, United States

  • Southern Urogynecology

    West Columbia, South Carolina, 29169, United States

  • Southern shores urogynecology

    Myrtle Beach, South Carolina, 29572, United States

  • Specialty Research of St. Louis

    St Louis, Missouri, 63141, United States

  • The Institute for Female Pelvic Medicine and Reconstructive Surgery

    North Wales, Pennsylvania, 19454, United States

  • The Oregon Clinic Urogynecology West

    Portland, Oregon, 97225, United States

  • Universiteit Antwerpen

    Antwerp, Belgium

  • University of Kansas Hospital

    Kansas City, Kansas, 66103-2937, United States

  • University of Michigan Health - West

    Wyoming, Michigan, 49519, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Washington

    Seattle, Washington, 98133, United States

  • UofL Health System (University of Louisville)

    Louisville, Kentucky, 40202, United States

  • Urology Austin

    Austin, Texas, 78745, United States

  • Urology Clinics of North Texas (Dallas Center for Pelvic Medicine)

    Dallas, Texas, 75231, United States

  • Virginia Mason

    Seattle, Washington, 98101, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Women's Health Advantage

    Fort Wayne, Indiana, 46825, United States

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