Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease (URGE-PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT01018264
First received: November 19, 2009
Last updated: May 7, 2015
Last verified: May 2015
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Overactive Bladder in Parkinson's Disease
Interventions: Drug: solifenacin succinate (VESIcare)
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Solifenacin Succinate (VESIcare) solifenacin succinate (VESIcare): up to 10mg every day orally
Placebo placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

Participant Flow:   Overall Study
    Solifenacin Succinate (VESIcare)     Placebo  
STARTED     10     13  
COMPLETED     9     12  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Solifenacin Succinate (VESIcare) solifenacin succinate (VESIcare): up to 10mg every day orally
Placebo placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Total Total of all reporting groups

Baseline Measures
    Solifenacin Succinate (VESIcare)     Placebo     Total  
Number of Participants  
[units: participants]
  10     13     23  
Age, Customized  
[units: years]
Mean (Standard Deviation)
     
Age (years)     67.6  (6.6)     66.5  (9.3)     66.96  (8.04)  
Gender  
[units: participants]
     
Female     3     5     8  
Male     7     8     15  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     9     12     21  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     1     1     2  
White     8     10     18  
More than one race     0     0     0  
Unknown or Not Reported     1     1     2  
Unified Parkinson's Disease Rating Scale (UPDRS) ADL subsection (mean) [1]
[units: units on a scale]
Mean (Standard Deviation)
  9.50  (5.40)     11.23  (4.76)     10.48  (5.01)  
Unified Parkinson's Disease Rating Scale (UPDRS) Motor subsection (Part III) [2]
[units: points]
Mean (Standard Deviation)
  12.60  (4.38)     14.69  (5.19)     13.78  (4.86)  
Unified Parkinson's Disease Rating Scale (UPDRS) Total score [3]
[units: units on a scale]
Mean (Standard Deviation)
  24.00  (9.67)     25.08  (11.93)     24.61  (10.78)  
Parkinson's Disease Quality of Life (PDQOL) total score [4]
[units: units on a scale]
Mean (Standard Deviation)
  124.10  (19.96)     115.31  (10.68)     119.13  (15.65)  
Hoehn & Yahr stage [5]
[units: participants]
     
Stage 1     1     0     1  
Stage 1.5     1     1     2  
Stage 2     1     2     3  
Stage 2.5     6     7     13  
Stage 3     1     3     4  
Incontinence Quality of Life scale (IQOL) [6]
[units: units on a scale]
Mean (Standard Deviation)
  78.00  (20.03)     75.92  (18.87)     76.83  (18.96)  
Bladder diary: # micturations [7]
[units: Micturation episodes per 24 hour period]
Mean (Standard Deviation)
  9.03  (2.21)     9.23  (3.31)     9.14  (2.83)  
Bladder diary: # leaks [8]
[units: Number of leaks per 24-hour period]
Mean (Standard Deviation)
  1.33  (2.45)     1.72  (1.23)     1.55  (1.82)  
Bladder diary: # nocturia episodes [9]
[units: Number of nocturia episodes per 24 hours]
Mean (Standard Deviation)
  2.23  (1.69)     1.90  (1.09)     2.04  (1.36)  
Patient perception of Bladder Condition (PBC/PPBC) [10]
[units: participants]
     
Causes me (some) moderate problems     5     5     10  
Causes me severe problems     4     7     11  
Causes me many severe problems     1     1     2  
Patient Perception of Intensity of Urgency Scale (PPIUS) [11]
[units: participants]
     
Mild Urgency     3     1     4  
Moderate Urgency     4     5     9  
Moderate-Severe     0     1     1  
Severe Urgency     3     6     9  
[1] 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.
[2] 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.
[3] 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.
[4] Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome).
[5] 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)
[6] The Incontinence Quality of Life scale has a possible range of 22 (worst outcome) to 110 (best outcome) total points.
[7] This is the mean number of micturations per 24 hour period as recorded on a 3-day bladder diary
[8] This is the mean number of leaks as recorded on a 3-day bladder diary.
[9] This is the mean number of nocturia episodes as recorded on a 3-day bladder diary.
[10] The PBC/PPBC is a single-item global measure for patients with overactive bladder.
[11] The PPIUS is a scale to assess patient's perception of their level of urgency. Mild urgency = better outcome; Severe urgency = worse outcome.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Micturations Per 24 Hour Period   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Urinary Incontinence Episodes Per 24 Hour Period   [ Time Frame: 12 weeks ]

3.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS) Total   [ Time Frame: 12 weeks ]

4.  Secondary:   Parkinson's Disease Quality of Life Scale (PDQOL)   [ Time Frame: 12 weeks ]

5.  Secondary:   Number of Nocturia Episodes Per 24 Hour Period   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Theresa Zesiewicz, MD, Professor of Neurology
Organization: University of South Florida
phone: 813-974-5909
e-mail: tzesiewi@health.usf.edu


No publications provided


Responsible Party: Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier: NCT01018264     History of Changes
Other Study ID Numbers: URGE-PD
Study First Received: November 19, 2009
Results First Received: April 15, 2015
Last Updated: May 7, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration