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

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ClinicalTrials.gov Identifier: NCT03817931
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : April 3, 2020
Sponsor:
Collaborators:
The Methodist Hospital System
International Urogynecological Association
Information provided by (Responsible Party):
Baylor Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Dementia Lower Urinary Tract Symptoms Incontinence, Urge Drug: Anticholinergic Drug: Beta-3 Agonists, Adrenergic Diagnostic Test: Functional magnetic resonance imaging (fMRI) Diagnostic Test: Rey Auditory Verbal Learning Test (RAVLT) Phase 4

Detailed Description:

Women presenting to the urology clinic with complaints of urinary urgency, frequency in the absence of urinary tract infection or other obvious pathology will be screened for inclusion/exclusion criteria. Qualifying subjects will be consented.

Baseline health information, bladder symptom questionnaires (Overactive Bladder-questionnaire(OABq), Patient Perception of Bladder Condition (PPBC)), Personal Health Questionnaire-9 (PHQ-9),Hamilton Anxiety Rating Scale (HAM-A), Montreal cognitive assessment (MoCA) will be given. If baseline depression (PHQ-9 score 15 or greater),dementia (MoCA score 25 or less), anxiety (HAM-A score 25-30) are noted the subject is excluded. 15 patients will be recruited from Baylor Scott & White Health Urology clinic, and 15 patients will be recruited from Houston Methodist Urology clinic.

They will schedule a date within 1 month for the Rey Auditory Verbal Learning Test (RAVLT) and brain functional MRI (fMRI). RAVLT test is performed, followed by resting state fMRI and memory task during fMRI. Vials of medication will be distributed. Vials will be labeled 1-30 and will contain 30 tablets each. The anticholinergic and beta-3 agonist tablets will be encapsulated to look identical to the placebo tablet. Subjects will be reimbursed at this visit. fMRI images at baseline and post-intervention will be analyzed by a radiologist for incidental findings.

One week and two weeks after initiating their tablets, phone interviews will inquire about pill count, side effects, and any new medications. Follow up testing date will be scheduled during the call. The same questions will be repeated at completion of the tablets (30 days after initiation).

At completion of the tablets, subjects return to Houston Methodist for repeat RAVLT and fMRI. Subjects will be reimbursed the other half of their compensation at this visit.

An expert physicist will analyze the BOLD signal intensity and FC pattern in a priori selected regions of interest before and after interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Permuted block stratified by recruitment site
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization using a random number system will be performed by the compounding pharmacy. Records linking subject number to their allocation will be kept by the pharmacy, inaccessible to the investigator, patient, care providers.
Primary Purpose: Prevention
Official Title: Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo pill identical will be identical to tablets in the other 2 arms.
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.
Other Name: cognitive testing

Active Comparator: Anticholinergic
Solifenacin 5 mg tablet orally once daily for 30 days
Drug: Anticholinergic
Tablet taken once daily.
Other Names:
  • Solifenacin
  • VESIcare

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.
Other Name: cognitive testing

Active Comparator: Beta-3 agonists, adrenergic
Mirabegron 25 mg tablet orally once daily for 30 days
Drug: Beta-3 Agonists, Adrenergic
Tablet taken once daily.
Other Names:
  • Mirabegron
  • Myrbetriq

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.
Other Name: cognitive testing




Primary Outcome Measures :
  1. Functional connectivity on MRI [ Time Frame: 29 +/-1 days ]
    Functional connectivity during a word recognition task will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.

  2. Resting state blood oxygenation level dependent (BOLD)changes [ Time Frame: 29 +/-1 days ]
    During resting state, BOLD changes will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.

  3. Diffusion tensor imaging [ Time Frame: 29 +/-1 days ]
    Fractional anisotropy and mean diffusivity from diffusion tensor images will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.


Secondary Outcome Measures :
  1. Score on Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 30 days ]
    Baseline testing will be compared with post-intervention testing

  2. Overactive bladder questionnaire (OAB-q) [ Time Frame: 30 days ]
    Baseline score of this validated questionnaire will be compared with post-intervention score

  3. Patient Perception of Bladder Condition (PPBC) [ Time Frame: 30 days ]
    Baseline score of this validated questionnaire will be compared with post-intervention score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female patients of age 50 to 90 years old with OAB as defined by the International Continence Society (Urgency with or without urge incontinence, usually with frequency and nocturia in the absence of urinary tract infection or other obvious pathology) who report that symptoms cause moderate problems using the PPBC.
  • English-speaking and able to consent

Exclusion Criteria:

  • Males are excluded to eliminate prostate pathology and urethral strictures, as well as possible bias of gender differences on fMRI.
  • Subjects with moderately severe or severe depression (screening score of 15 or more) on the Personal Health Questionnaire-9 (PHQ-9)
  • Subjects with moderate to severe anxiety (screening score 25-30) on the Hamilton Anxiety Rating Scale (HAM-A)
  • A screening score indicating below normal cognitive function at baseline (score of 25 or less) on the montreal cognitive assessment.
  • Subjects with neurologic disorders, dementia, prior cerebrovascular accident, neurogenic bladder or post-void residual greater than 250 mL
  • Anticholinergics for OAB or beta 3 agonists use for treatment of OAB in the preceding six months prior to enrollment
  • Pregnant or planning to become pregnant in the next six months, or current breastfeeding
  • The inability to undergo MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817931


Contacts
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Contact: Jill M Danford, MD 2547621857 highr077@gmail.com
Contact: Rachel High, DO 4025257006 highr077@gmail.com

Locations
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United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Hamida Rajab         
Principal Investigator: Rose Khavai, MD         
Baylor Scott and White Health Recruiting
Temple, Texas, United States, 75608
Contact: Rachel High    254-724-2102      
Sub-Investigator: Rachel High, DO         
Principal Investigator: Jill Danford, MD         
Sponsors and Collaborators
Baylor Research Institute
The Methodist Hospital System
International Urogynecological Association
Investigators
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Principal Investigator: Jill Danford, MD Baylor Scott and White Health
Principal Investigator: Rose Khavari, MD The Methodist Hospital System
Principal Investigator: Rachel High, DO Baylor Scott and White Health
Additional Information:
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03817931    
Other Study ID Numbers: 160362
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Urinary Incontinence
Urination Disorders
Solifenacin Succinate
Mirabegron
Cholinergic Antagonists
Adrenergic beta-3 Receptor Agonists
Adrenergic Agents
Adrenergic Agonists
Muscarinic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-Agonists