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Daily pill aims to improve bladder function in children with spinal conditions

NCT ID NCT05491525

Disease control Sponsor: Urovant Sciences GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 daily pill called vibegron to see if it safely improves bladder control in children aged 2 to 18 with neurogenic detrusor overactivity (NDO), a condition where the bladder contracts too often due to nerve damage. Participants must already use a catheter to empty their bladder. The trial measures changes in bladder capacity and pressure during filling, aiming to reduce leakage and improve quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vibegron
What this could lead to
If successful, vibegron could offer a new oral treatment option to help children with neurogenic bladder hold more urine and reduce involuntary bladder contractions.
What could go wrong
This is an early-to-mid-stage trial with no placebo group, so results may be less definitive. Side effects or lack of efficacy could limit its use.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 71 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Sep 2030

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

2 to 17 years

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: * Male or female participants, age 2 years to \< 18 years and weighing at least 11 kg at the Screening Visit. * Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele, meningocele) and all forms of tethered cord; or acquired NDO from a spinal cord injury or spinal cord surgery, with the injury/surgery having occurred at least 6 months prior to the Screening Visit; or acquired NDO due to transverse myelitis with diagnosis at least 12 months prior to the Screening Visit. * Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks prior to the Screening Visit. Exclusion Criteria: * Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension * Participant has an active malignancy in the 12 months prior to the Screening Visit. * Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during the study. * Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study. * Participant currently uses or plans to use a baclofen pump during the study. * Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit. * Participant has undergone bladder augmentation surgery. * Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones or another persistent urinary tract pathology that may cause symptoms. * Participant has an insufficient urethral sphincter, has had implantation of an artificial sphincter, has a surgically-treated underactive urethral sphincter, or, in the 6 months prior to the Screening Visit, has undergone pelvic gender reassignment surgery. * Participant has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, risk of gastric retention, or malabsorption syndrome of any form. * Participant has acute fecal impaction or, within the 3 months prior to the Screening Visit, had fecal impaction that required hospitalization or ambulatory surgical treatment. * Participant had a urinary indwelling catheter in the 4 weeks prior to the Screening Visit. * Participant has moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure. * Participant started electrostimulation/neuromodulation therapy in the 4 weeks before the Screening Visit, or is expected to start this therapy during the study period. * Participant has participated in another clinical trial and/or has taken an investigational drug within 4 weeks prior to the Screening Visit. * Participant is unable, or parent/caregiver is not willing, to washout any medication for the management of NDO. * Participant is a female of childbearing potential who is unwilling or unable to use a highly effective method of contraception for the duration of the study. * Female participants who are currently breastfeeding or plan to breastfeed any time from the Screening Visit until 28 days after the final study drug administration.

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Conditions

The condition(s) this trial relates to.

acute transverse myelitis meningocele myelomeningocele overactive bladder spina bifida spinal cord injury

As listed by the trial registrant

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

Neurogenic detrusor overactivity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 15 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine

    RECRUITING

    Aarhus, 8200, Denmark

  • Albany Medical College

    RECRUITING

    Albany, New York, 12208, United States

  • Alberta Children's Hospital

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Ankara University Faculty of Medicine Ibni Sina Hospital

    RECRUITING

    Ankara, Altindag, 6230, Turkey (Türkiye)

  • Arkansas Childrens Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Children and Youth Health Care Institute of Vojvodina

    RECRUITING

    Novi Sad, 21000, Serbia

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 800045, United States

  • Children's Hospital of Orange County

    TERMINATED

    Orange, California, 92868-4568, United States

  • Childrens Clinical University Hospital

    WITHDRAWN

    Riga, LV-1004, Latvia

  • Childrens Hospital New Orleans

    WITHDRAWN

    New Orleans, Louisiana, 70118, United States

  • Detská fakultná nemocnica s poliklinikou/Národný ústav detských chorôb (NÚDCH)

    RECRUITING

    Bratislava, 83301, Slovakia

  • Duke University Medical Center

    TERMINATED

    Durham, North Carolina, 27710, United States

  • Hospital Umum Sarawak

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    RECRUITING

    Kaunas, LT-50161, Lithuania

  • Institutul Clinic Fundeni

    RECRUITING

    Bucharest, Bucharest, 22328, Romania

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    RECRUITING

    Warsaw, 04-736, Poland

  • Irbid Specialty Hospital

    RECRUITING

    Irbid, 21110, Jordan

  • Istiklal Hospital

    RECRUITING

    Amman, 11821, Jordan

  • JSC Evex Hospital M. lashvili Childrens Central Hospital

    RECRUITING

    Tbilisi, 0159, Georgia

  • Jordan University Hospital

    RECRUITING

    Amman, 11942, Jordan

  • Kuala Lumpur Hospital

    RECRUITING

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Maria Sklodowska Curie Childrens Clinical Emergency Hospital

    RECRUITING

    Bucharest, Bucharest, 41451, Romania

  • Mersin University, Dept. of Urology

    RECRUITING

    Yenişehir, 33343, Turkey (Türkiye)

  • National Children's Hospital

    RECRUITING

    Quezon City, National Capital Region, 1102, Philippines

  • Nemours Childrens Health, Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Oregon Health & Science University

    WITHDRAWN

    Portland, Oregon, 97239, United States

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1E8, Canada

  • UZ Gent

    RECRUITING

    Ghent, East Flanders, 9000, Belgium

  • Universitair Ziekenhuis Antwerpen

    WITHDRAWN

    Edegem, Antwerpen, 2650, Belgium

  • University Children's Hospital Tirsova

    RECRUITING

    Belgrade, 11000, Serbia

  • University Hospital Split - KBC Split

    RECRUITING

    Split, 21000, Croatia

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

    RECRUITING

    Bialystok, 15-274, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-952, Poland

  • Urologická ambulancia J. BREZA MEDICAL s.r.o.

    RECRUITING

    Bratislava, 85101, Slovakia

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, LT-08406, Lithuania

  • Wichita Urology Group

    RECRUITING

    Wichita, Kansas, 67226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.