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NCT05491525Possibly a fitRecruiting

Vibegron for children with nerve bladder using intermittent catheter

Neurogenic Detrusor Overactivity

Part of Brain & nervous system, Cancer, Genetic & congenital, Immune system & allergy, Infections, Injuries & trauma clinical trials.

This study tests how well and how safely vibegron works long-term in children (ages 2 to under 18) with a nerve-related bladder condition, who regularly use intermittent catheterization. It also tracks how the body processes the medicine and whether it helps bladder control over time.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
71 people
Ages
2 years to 17 years
Study type
Interventional

Who can take part

  • You’re between 2 and under 18 years old, and you weigh at least 11 kg.
  • You have a diagnosed nerve bladder problem (NDO) such as spina bifida/tethered cord, or NDO after spinal cord injury/surgery (at least 6 months ago), or after transverse myelitis (diagnosed at least 12 months ago).
  • You do intermittent catheterization (CIC) at least 3 times in 24 hours, including a catheter before bedtime, for at least 4 weeks before screening.
  • You do NOT have certain other conditions or situations (like cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or stage 2 high blood pressure).
  • You have not had certain bladder procedures or therapies recently (for example, botulinum toxin in the last 9 months, or an indwelling catheter in the last 4 weeks).
  • You can pause (“wash out”) other NDO medications if needed for the study, as directed by the team.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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