A Phase 4 interventional study of Trospium Chloride and Placebo in Mental Competency, Urinary Bladder, Overactive and Cognitive Function, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 50 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by University of North Carolina, Chapel Hill · Phase 4, Interventional, and Basic science
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:
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 59 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Drug: Trospium Chloride
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Drug: Placebo
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.
Also known as: Sanctura XR
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
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
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
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
| Milestone | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| Started | 28 | 31 |
| Completed | 21 | 24 |
| Not completed | 7 | 7 |
Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.
| units on a scale | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| Immediate Recall | 22.00 ± 5.51 | 24.38 ± 5.96 |
| Delayed Recall | 6.71 ± 2.80 | 7.83 ± 3.28 |
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.
| units on a scale | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| Mini-Mental State Examination | 28.14 ± 1.90 | 28.38 ± 1.76 |
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.
| units on a scale | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| Overactive Bladder Questionnaire | 41.45 ± 18.84 | 56.04 ± 20.21 |
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.
| percentage of total correct | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| Hopkins Verbal Learning Test - Revised | 81.68 ± 47.45 | 83.49 ± 26.72 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TROSPIUM CHLORIDE | — | 2/28 (7.1%) | 10/28 (35.7%) |
| PLACEBO | — | 0/31 (0%) | 2/31 (6.5%) |
| Event | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| Pulmonary DistressRespiratory, thoracic and mediastinal disorders | 1/28 | 0/31 |
| Blood ClotVascular disorders | 1/28 | 0/31 |
| Event | TROSPIUM CHLORIDE | PLACEBO |
|---|---|---|
| ConstipationGastrointestinal disorders | 4/28 | 1/31 |
| Dry MouthGastrointestinal disorders | 4/28 | 0/31 |
| DepressionPsychiatric disorders | 1/28 | 0/31 |
| UTIRenal and urinary disorders | 1/28 | 0/31 |
| DizzinessGeneral disorders | 1/28 | 0/31 |
| Skin RashSkin and subcutaneous tissue disorders | 1/28 | 0/31 |
| Dry EyesEye disorders | 0/28 | 1/31 |
| Mood SwingsPsychiatric disorders | 0/28 | 1/31 |
| Age, Continuous(years) | TROSPIUM CHLORIDE | PLACEBO | Total |
|---|---|---|---|
| Mean | 68.39 ± 11.615 | 68.71 ± 10.615 | 68.56 ± 11.005 |
| Sex: Female, Male(Participants) | TROSPIUM CHLORIDE | PLACEBO | Total |
|---|---|---|---|
| Female | 28 | 31 | 59 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | TROSPIUM CHLORIDE | PLACEBO | Total |
|---|---|---|---|
| White | 7 | 25 | 32 |
| Black | 21 | 4 | 25 |
| Hispanic | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 |
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University of North Carolina, Chapel Hill