Tests vibegron for bladder overactivity in children using catheters
Tests vibegron in children aged 2 to under 18 with overactive bladder from nerve damage.
Plain-language title generated from the registry record
Registry title: Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
Key facts
- Where
- Calgary and Toronto, CanadaSee the 2 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with a bladder problem caused by a nerve condition, who empty their bladder with a catheter several times a day.
- Age
- 2 years to under 18 years, weighing at least 11 kg (24 lb)
- Sex
- Boys and girls
- Disease stage
- Neurogenic detrusor overactivity (NDO) caused by spinal dysraphism (including spina bifida and tethered cord), a spinal cord injury or surgery at least 6 months ago, or transverse myelitis diagnosed at least 12 months ago
- Earlier treatment
- Must have used clean intermittent catheterization (CIC) at least 3 times per 24 hours for at least 4 weeks. Must not have had botulinum toxin in the bladder within the last 9 months.
Main reasons for not taking part
- Cerebral palsy, uncontrolled epilepsy, diabetes insipidus or Stage 2 hypertension
- Active cancer in the last 12 months
- Taking digoxin or lithium, or using a baclofen pump
- Bladder augmentation surgery or another urinary tract condition that can cause incontinence
- Taking part in another trial or taking an investigational drug in the last 4 weeks
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT05491525, who can take part
Where in Canada
- Alberta Children's HospitalCalgary, CanadaContact: Bryce Weber (principal investigator)Taking people
- The Hospital for Sick ChildrenToronto, CanadaContact: Michael Chua (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Urovant Sciences GmbH
- Trial code
- NCT05491525
- Record updated
- 15 June 2026
- Original description
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CICRead full original descriptionShow less
A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
Inclusion: 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: 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 has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit; Participant has undergone bladder augmentation surgery; 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 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 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; 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; Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension; 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 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 moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure; Participant currently uses or plans to use a baclofen pump during the study; 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.