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

NCT03817931 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-02-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Anticholinergic

Tablet taken once daily.

DRUG

Beta-3 Agonists, Adrenergic

Tablet taken once daily.

DIAGNOSTIC_TEST

Functional magnetic resonance imaging (fMRI)

All subjects have fMRI at baseline and again after 30 days

DIAGNOSTIC_TEST

Rey Auditory Verbal Learning Test (RAVLT)

All subjects have RAVLT at baseline and again after 30 days. RAVLT evaluates: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • International Urogynecological Association

    collaborator OTHER

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Jill Danford, MD · Baylor Scott and White Health

  • Rose Khavari, MD · The Methodist Hospital Research Institute

  • Rachel High, DO · Baylor Scott and White Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2022-02-02
Completion
2022-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03817931 on ClinicalTrials.gov