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| Name | Class |
|---|---|
| The Methodist Hospital Research Institute | OTHER |
| International Urogynecological Association | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo pill identical will be identical to tablets in the other 2 arms. |
|
| Anticholinergic | Active Comparator | Solifenacin 5 mg tablet orally once daily for 30 days |
|
| Beta-3 agonists, adrenergic | Active Comparator | Mirabegron 25 mg tablet orally once daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticholinergic | Drug | Tablet taken once daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional connectivity on MRI | Functional connectivity during a word recognition task will be compared within subjects from baseline and after 29+/- 1 day of intervention medication. | 29 +/-1 days |
| Resting state blood oxygenation level dependent (BOLD)changes | During resting state, BOLD changes will be compared within subjects from baseline and after 29+/- 1 day of intervention medication. | 29 +/-1 days |
| Diffusion tensor imaging | Fractional anisotropy and mean diffusivity from diffusion tensor images will be compared within subjects from baseline and after 29+/- 1 day of intervention medication. | 29 +/-1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Rey Auditory Verbal Learning Test (RAVLT) | Baseline testing will be compared with post-intervention testing | 30 days |
| Overactive bladder questionnaire (OAB-q) | Baseline score of this validated questionnaire will be compared with post-intervention score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Danford, MD | Baylor Scott and White Health | Principal Investigator |
| Rose Khavari, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Rachel High, DO | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States | ||
| Baylor Scott and White Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37160401 | Derived | Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3. |
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There is not a plan.
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Permuted block stratified by recruitment site
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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.
| Beta-3 Agonists, Adrenergic | Drug | Tablet taken once daily. |
|
|
| Functional magnetic resonance imaging (fMRI) | Diagnostic Test | All subjects have fMRI at baseline and again after 30 days |
|
| Rey Auditory Verbal Learning Test (RAVLT) | Diagnostic Test | 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. |
|
|
| 30 days |
| Patient Perception of Bladder Condition (PPBC) | Baseline score of this validated questionnaire will be compared with post-intervention score | 30 days |
| Temple |
| Texas |
| 75608 |
| United States |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D003704 | Dementia |
| D059411 | Lower Urinary Tract Symptoms |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| D018680 | Cholinergic Antagonists |
| D000069464 | Solifenacin Succinate |
| D058667 | Adrenergic beta-3 Receptor Agonists |
| C520025 | mirabegron |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D018678 | Cholinergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000318 | Adrenergic beta-Agonists |
| D000322 | Adrenergic Agonists |
| D018663 | Adrenergic Agents |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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