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This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solifenacin succinate (VESIcare) | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin succinate (VESIcare) | Drug | up to 10mg every day orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Micturations Per 24 Hour Period | The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Urinary Incontinence Episodes Per 24 Hour Period | This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity. | 12 weeks |
| Unified Parkinson's Disease Rating Scale (UPDRS) Total |
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Inclusion Criteria:
Exclusion Criteria:
Any illness that in the investigator's opinion preclude participation in this study.
Pregnancy or lactation.
Concurrent participation in another clinical study.
Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27).
Legal incapacity or limited legal capacity.
History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit.
Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
History of narrow angle glaucoma.
Patients who have undergone pelvic radiation at any time.
Currently taking any of the following medications:
Urinary obstruction in male PD patients as diagnosed by a urologist
Active urinary tract infection.
Patients with a history of chronic severe constipation (by self report)
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Zesiewicz, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| University of South Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solifenacin Succinate (VESIcare) | solifenacin succinate (VESIcare): up to 10mg every day orally |
| FG001 | Placebo | placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Solifenacin Succinate (VESIcare) | solifenacin succinate (VESIcare): up to 10mg every day orally |
| BG001 | Placebo | placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Micturations Per 24 Hour Period | The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries. | Posted | Mean | Standard Deviation | Number of micturations per 24 hours | 12 weeks |
|
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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 | Solifenacin Succinate (VESIcare) | solifenacin succinate (VESIcare): up to 10mg every day orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Zesiewicz, MD, Professor of Neurology | University of South Florida | 813-974-5909 | tzesiewi@health.usf.edu |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| D010300 | Parkinson Disease |
| 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 |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| placebo |
| Drug |
placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day |
|
To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability). |
| 12 weeks |
| Parkinson's Disease Quality of Life Scale (PDQOL) | This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life. | 12 weeks |
| Number of Nocturia Episodes Per 24 Hour Period | To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity | 12 weeks |
| Tampa |
| Florida |
| 33612 |
| United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Unified Parkinson's Disease Rating Scale (UPDRS) ADL subsection (mean) | This subscale of the UPDRS measures activities of daily living. Points can range from 0-52 with 0 being better outcomes and 52 being a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Unified Parkinson's Disease Rating Scale (UPDRS) Motor subsection (Part III) | This is part III of the UPDRS scale. It measures motor function in PD patients. Scores range from 0 to 108, with a score of 0 being a better outcome and 108 being a worse outcome. | Mean | Standard Deviation | points |
|
| Unified Parkinson's Disease Rating Scale (UPDRS) Total score | The UPDRS is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of: Part 1- Mentation, Behavior, and Mood; Part 2- Activities of Daily Living (ADL); Part 3 - Motor function; and Part IV - Complications. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total disability), 0 =no disability. To get the total score you sum up each subsection score. | Mean | Standard Deviation | units on a scale |
|
| Parkinson's Disease Quality of Life (PDQOL) total score | Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). | Mean | Standard Deviation | units on a scale |
|
| Hoehn & Yahr stage | Stage 1: Unilateral disease. (Better outcome) Stage 1.5: Unilateral plus axial involvement. Stage 2: Bilateral disease, without impairment of balance. Stage 2.5: Mild bilateral disease, with recovery on pull test. Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent. (Worst Outcome) | Number | participants |
|
| Incontinence Quality of Life scale (IQOL) | The Incontinence Quality of Life scale has a possible range of 22 (worst outcome) to 110 (best outcome) total points. | Mean | Standard Deviation | units on a scale |
|
| Bladder diary: # micturations | This is the mean number of micturations per 24 hour period as recorded on a 3-day bladder diary | Mean | Standard Deviation | Micturation episodes per 24 hour period |
|
| Bladder diary: # leaks | This is the mean number of leaks as recorded on a 3-day bladder diary. | Mean | Standard Deviation | Number of leaks per 24-hour period |
|
| Bladder diary: # nocturia episodes | This is the mean number of nocturia episodes as recorded on a 3-day bladder diary. | Mean | Standard Deviation | Number of nocturia episodes per 24 hours |
|
| Patient perception of Bladder Condition (PBC/PPBC) | The PBC/PPBC is a single-item global measure for patients with overactive bladder. | Number | participants |
|
| Patient Perception of Intensity of Urgency Scale (PPIUS) | The PPIUS is a scale to assess patient's perception of their level of urgency. Mild urgency = better outcome; Severe urgency = worse outcome. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Urinary Incontinence Episodes Per 24 Hour Period | This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity. | Posted | Mean | Standard Deviation | Number of incontinence episodes/24 hours | 12 weeks |
|
|
|
|
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Total | To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability). | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Parkinson's Disease Quality of Life Scale (PDQOL) | This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Number of Nocturia Episodes Per 24 Hour Period | To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity | Posted | Mean | Standard Deviation | Number of nocturia episodes per 24 hours | 12 weeks |
|
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Placebo | placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day | 0 | 13 | 0 | 13 |
| Xerostomia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| urinary retention | Renal and urinary disorders | Systematic Assessment |
|
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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 |
| D014555 | Urination Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |