Overactive Bladder
Conditions
Brief summary
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
Interventions
trospium chloride (60mg) once daily for 10 days
DRUGoxybutynin IR
oxybutynin IR (5 mg) three times daily for 2 days
DRUGoxybutynin IR placebo
oxybutynin IR placebo three times daily for 2 days
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient presents symptoms of overactive bladder * Patient has age associated memory impairment * No acute or unstable medical conditions
Exclusion criteria
* History of alcohol or substance abuse within 1 year prior to study * Has donated in excess of 500mL of blood or plasma in the 30 days prior to study * Has known bleeding disorder (hemophilia) * Previous abdominal bypass surgery for obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose | Day 10 Post-Dose | Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®. |
| Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Day 2 Post-Dose | Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Levels of Sanctura XR® at Day 10 Post-dose | Day 10 Post-Dose | Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. |
| Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Day 2 Post-Dose | Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. |
| Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Baseline, 10 Days | Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory. |
| Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Baseline, 10 Days | Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. |
| Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Baseline, 10 Days | Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory. |
| Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Baseline, 10 Days | Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sanctura XR® Sanctura XR® (60mg) once daily for 10 days | 6 |
| Oxybutynin IR Oxybutynin IR (5 mg) three times daily for 2 days | 10 |
| Oxybutynin IR Placebo Oxybutynin IR placebo three times daily for 2 days | 4 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sanctura XR® | Oxybutynin IR | Oxybutynin IR Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 74.4 Years STANDARD_DEVIATION 6.3 | 68.3 Years STANDARD_DEVIATION 6.1 | 77.6 Years STANDARD_DEVIATION 12.3 | 72.0 Years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 7 / 10 | 2 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 10 | 0 / 4 |
Outcome results
Primary
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
Time frame: Day 2 Post-Dose
Population: All patients who received Oxybutynin IR
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxybutynin IR | Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Oxybutynin | 0.0597 Nanograms (ng) per milliliter (mL) | Standard Deviation 0.0309 |
| Oxybutynin IR | Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | N-Desethyl-Oxybutynin | 0.386 Nanograms (ng) per milliliter (mL) | Standard Deviation 0.235 |
Primary
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.
Time frame: Day 10 Post-Dose
Population: All patients who received Sanctura XR®
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sanctura XR® | Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose | NA Nanograms (ng) per milliliter (mL) |
Secondary
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.
Time frame: Baseline, 10 Days
Population: Per Protocol: All subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sanctura XR® | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Baseline | 6.0 Scores on a Scale | Standard Deviation 4.2 |
| Sanctura XR® | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Change from Baseline up to Day 10 | 0.2 Scores on a Scale | Standard Deviation 3.4 |
| Oxybutynin IR | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Baseline | 8.0 Scores on a Scale | Standard Deviation 3.6 |
| Oxybutynin IR | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Change from Baseline up to Day 10 | -1.8 Scores on a Scale | Standard Deviation 3.5 |
| Oxybutynin IR Placebo | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Baseline | 4.5 Scores on a Scale | Standard Deviation 5.3 |
| Oxybutynin IR Placebo | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Change from Baseline up to Day 10 | 2.3 Scores on a Scale | Standard Deviation 3.9 |
Secondary
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.
Time frame: Baseline, 10 Days
Population: Per Protocol: All subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sanctura XR® | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Change from Baseline up to Day 10 | -1.2 Scores on a Scale | Standard Deviation 1.5 |
| Sanctura XR® | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Baseline | 8.2 Scores on a Scale | Standard Deviation 1.2 |
| Oxybutynin IR | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Baseline | 9.4 Scores on a Scale | Standard Deviation 2.1 |
| Oxybutynin IR | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Change from Baseline up to Day 10 | -1.3 Scores on a Scale | Standard Deviation 1.6 |
| Oxybutynin IR Placebo | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Baseline | 8.8 Scores on a Scale | Standard Deviation 2.1 |
| Oxybutynin IR Placebo | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Change from Baseline up to Day 10 | -0.3 Scores on a Scale | Standard Deviation 3.7 |
Secondary
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory.
Time frame: Baseline, 10 Days
Population: Per Protocol: All subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sanctura XR® | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Baseline | 15.8 Scores on a Scale | Standard Deviation 6.6 |
| Sanctura XR® | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Change from Baseline up to Day 10 | 1.2 Scores on a Scale | Standard Deviation 7.4 |
| Oxybutynin IR | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Baseline | 20.3 Scores on a Scale | Standard Deviation 9.9 |
| Oxybutynin IR | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Change from Baseline up to Day 10 | -1.1 Scores on a Scale | Standard Deviation 5.3 |
| Oxybutynin IR Placebo | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Baseline | 16.8 Scores on a Scale | Standard Deviation 11.3 |
| Oxybutynin IR Placebo | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Change from Baseline up to Day 10 | 0.0 Scores on a Scale | Standard Deviation 3.5 |
Secondary
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.
Time frame: Baseline, 10 Days
Population: Per Protocol: All subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sanctura XR® | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Baseline | 22.5 Scores on a Scale | Standard Deviation 2.9 |
| Sanctura XR® | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Change from Baseline up to Day 10 | -0.3 Scores on a Scale | Standard Deviation 3.3 |
| Oxybutynin IR | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Baseline | 24.4 Scores on a Scale | Standard Deviation 3.3 |
| Oxybutynin IR | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Change from Baseline up to Day 10 | -3.3 Scores on a Scale | Standard Deviation 5.4 |
| Oxybutynin IR Placebo | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Baseline | 24.0 Scores on a Scale | Standard Deviation 3.7 |
| Oxybutynin IR Placebo | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Change from Baseline up to Day 10 | -2.0 Scores on a Scale | Standard Deviation 4.8 |
Secondary
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Time frame: Day 2 Post-Dose
Population: All patients who received of Oxybutynin IR
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxybutynin IR | Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Oxybutynin | 8.80 Nanograms (ng) per milliliter (mL) | Standard Deviation 2.84 |
| Oxybutynin IR | Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | N-Desethyl-Oxybutynin | 47.0 Nanograms (ng) per milliliter (mL) | Standard Deviation 11.2 |
Secondary
Plasma Levels of Sanctura XR® at Day 10 Post-dose
Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Time frame: Day 10 Post-Dose
Population: All patients who received of Sanctura XR®
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sanctura XR® | Plasma Levels of Sanctura XR® at Day 10 Post-dose | 1.47 Nanograms (ng) per milliliter (mL) | Standard Deviation 1.03 |