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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
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Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
Subjects will be randomized to: 1) trospium chloride or 2) placebo.
There are three aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TROSPIUM CHLORIDE | Active Comparator | Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg). |
|
| PLACEBO | Placebo Comparator | Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trospium Chloride | Drug | Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Verbal Learning Test - Revised | Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes. | Week 4 |
| Hopkins Verbal Learning Test - Revised | Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination | The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Geller, MD | UNC CHAPEL HILL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unc Chapel Hill Urogynecology A2 Clinic | Chapel Hill | North Carolina | 27517 | United States |
| 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. | |
| 28067745 | Derived | Geller EJ, Dumond JB, Bowling JM, Khandelwal CM, Wu JM, Busby-Whitehead J, Kaufer DI. Effect of Trospium Chloride on Cognitive Function in Women Aged 50 and Older: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):118-123. doi: 10.1097/SPV.0000000000000374. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TROSPIUM CHLORIDE | Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg). Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit. |
| FG001 | PLACEBO | Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride). Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TROSPIUM CHLORIDE | Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg). Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hopkins Verbal Learning Test - Revised | Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TROSPIUM CHLORIDE | Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg). Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Distress | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Geller | UNC Chapel Hill | 919-966-4717 | elizabeth_geller@med.unc.edu |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C003330 | trospium chloride |
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|
| Placebo | Drug |
|
| Overactive Bladder Questionnaire | The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes. | Week 4 |
| BG001 | PLACEBO | Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride). Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
| Secondary | Mini-Mental State Examination | The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| Secondary | Overactive Bladder Questionnaire | The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| Primary | Hopkins Verbal Learning Test - Revised | Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes. | Posted | Mean | Standard Deviation | percentage of total correct | Week 4 |
|
|
|
| 2 |
| 28 |
| 10 |
| 28 |
| EG001 | PLACEBO | Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride). Placebo | 0 | 31 | 2 | 31 |
| Blood Clot | Vascular disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Depression | Psychiatric disorders |
|
| UTI | Renal and urinary disorders |
|
| Dizziness | General disorders |
|
| Skin Rash | Skin and subcutaneous tissue disorders |
|
| Dry Eyes | Eye disorders |
|
| Mood Swings | Psychiatric disorders |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |