Mental Competency, Urinary Bladder, Overactive, Cognitive Function
Conditions
Keywords
COGNITIVE FUNCTION, OVERACTIVE BLADDER, [C23.888.942.343.780]
Brief summary
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.
Detailed description
Subjects will be randomized to: 1) trospium chloride or 2) placebo. There are three aims: 1. To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests 2. To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management 3. To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.
Interventions
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.
DRUGPlacebo
Sponsors
American Urogynecologic Society
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Female 50 or older * Diagnosis of OAB (ICS definition) * English literacy * Ability to swallow oral medication * Cognitive ability to give consent
Exclusion criteria
* Dementia/Depression/Delirium * Current anticholinergic use (requires 2 week washout period) * Current cholinesterase * Urinary or gastric retention * Severe decreased gastrointestinal motility * Uncontrolled narrow-angle glaucoma * Myasthenia gravis * Diagnosis fo renal impairment (creatinine clearance \<30 mL/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hopkins Verbal Learning Test - Revised | Week 4 | Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination | Week 4 | 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. |
| Overactive Bladder Questionnaire | Week 4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| PLACEBO Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo | 31 |
| Total | 59 |
Baseline characteristics
| Characteristic | TROSPIUM CHLORIDE | PLACEBO | Total |
|---|---|---|---|
| Age, Continuous | 68.39 years STANDARD_DEVIATION 11.615 | 68.71 years STANDARD_DEVIATION 10.615 | 68.56 years STANDARD_DEVIATION 11.005 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 21 participants | 4 participants | 25 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 7 participants | 25 participants | 32 participants |
| Sex: Female, Male Female | 28 Participants | 31 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 28 | 2 / 31 |
| serious Total, serious adverse events | 2 / 28 | 0 / 31 |
Outcome results
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.
Time frame: Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TROSPIUM CHLORIDE | Hopkins Verbal Learning Test - Revised | Immediate Recall | 22.00 units on a scale | Standard Deviation 5.51 |
| TROSPIUM CHLORIDE | Hopkins Verbal Learning Test - Revised | Delayed Recall | 6.71 units on a scale | Standard Deviation 2.8 |
| PLACEBO | Hopkins Verbal Learning Test - Revised | Immediate Recall | 24.38 units on a scale | Standard Deviation 5.96 |
| PLACEBO | Hopkins Verbal Learning Test - Revised | Delayed Recall | 7.83 units on a scale | Standard Deviation 3.28 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TROSPIUM CHLORIDE | Hopkins Verbal Learning Test - Revised | 81.68 percentage of total correct | Standard Deviation 47.45 |
| PLACEBO | Hopkins Verbal Learning Test - Revised | 83.49 percentage of total correct | Standard Deviation 26.72 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TROSPIUM CHLORIDE | Mini-Mental State Examination | 28.14 units on a scale | Standard Deviation 1.9 |
| PLACEBO | Mini-Mental State Examination | 28.38 units on a scale | Standard Deviation 1.76 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TROSPIUM CHLORIDE | Overactive Bladder Questionnaire | 41.45 units on a scale | Standard Deviation 18.84 |
| PLACEBO | Overactive Bladder Questionnaire | 56.04 units on a scale | Standard Deviation 20.21 |