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NCT03817931

Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder

Completed Phase 4 Last updated 2 February 2024
What this trial tests

Phase 4 trial testing Anticholinergic in Overactive Bladder in 12 participants. Completed in 26 February 2022.

Timeline
5 August 2019
Primary endpoint
2 February 2022
26 February 2022

Quick facts

Lead sponsorBaylor Research Institute
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment12
Start date5 August 2019
Primary completion2 February 2022
Estimated completion26 February 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor Research Institute

Who can join

Adults 18 to 90, female only, with Overactive Bladder or Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Women presenting with overactive bladder symptoms will be randomized to one of 3 arms (anticholinergic, beta-3 agonist, placebo). They will undergo baseline cognitive testing, functional MRI of the brain. Cognitive testing and functional MRI will be repeated after taking their double blinded intervention for 30 days.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults.
    Stoniute A, Madhuvrata P, Still M, Barron-Millar E, et al · · 2023 · cited 12× · PMID 37160401 · DOI 10.1002/14651858.cd003781.pub3
  2. Protocol for a multicenter randomized, double blind, controlled pilot trial of higher neural function in overactive bladder patients after anticholinergic, beta-3 adrenergic agonist, or placebo.
    High RA, Danford JM, Shi Z, Karmonik C, et al · · 2020 · cited 4× · PMID 32728649 · DOI 10.1016/j.conctc.2020.100621
  3. The effect of oral medications on fMRI brain activation: A randomized, double blind, controlled pilot trial of older women with overactive bladder.
    High RA, Shi Z, Danford JM, Bird ET, et al · · 2023 · cited 2× · PMID 35925203 · DOI 10.1007/s00192-022-05300-8

Verify or expand the search:

Other trials of Anticholinergic

Trials testing the same drug.

Other recruiting trials for Overactive Bladder

Currently open trials in the same condition.

Other Baylor Research Institute trials

Trials by the same sponsor.

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Data sources for this page

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