Trial Outcomes & Findings for Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease (NCT NCT01018264)
NCT ID: NCT01018264
Last Updated: 2021-11-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-11-09
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Solifenacin Succinate (VESIcare)
n=10 Participants
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=13 Participants
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years)
|
67.6 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
66.5 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
66.96 years
STANDARD_DEVIATION 8.04 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) ADL subsection (mean)
|
9.50 units on a scale
STANDARD_DEVIATION 5.40 • n=99 Participants
|
11.23 units on a scale
STANDARD_DEVIATION 4.76 • n=107 Participants
|
10.48 units on a scale
STANDARD_DEVIATION 5.01 • n=206 Participants
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Motor subsection (Part III)
|
12.60 points
STANDARD_DEVIATION 4.38 • n=99 Participants
|
14.69 points
STANDARD_DEVIATION 5.19 • n=107 Participants
|
13.78 points
STANDARD_DEVIATION 4.86 • n=206 Participants
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total score
|
24.00 units on a scale
STANDARD_DEVIATION 9.67 • n=99 Participants
|
25.08 units on a scale
STANDARD_DEVIATION 11.93 • n=107 Participants
|
24.61 units on a scale
STANDARD_DEVIATION 10.78 • n=206 Participants
|
|
Parkinson's Disease Quality of Life (PDQOL) total score
|
124.10 units on a scale
STANDARD_DEVIATION 19.96 • n=99 Participants
|
115.31 units on a scale
STANDARD_DEVIATION 10.68 • n=107 Participants
|
119.13 units on a scale
STANDARD_DEVIATION 15.65 • n=206 Participants
|
|
Hoehn & Yahr stage
Stage 1
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Hoehn & Yahr stage
Stage 1.5
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Hoehn & Yahr stage
Stage 2
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Hoehn & Yahr stage
Stage 2.5
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Hoehn & Yahr stage
Stage 3
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Incontinence Quality of Life scale (IQOL)
|
78.00 units on a scale
STANDARD_DEVIATION 20.03 • n=99 Participants
|
75.92 units on a scale
STANDARD_DEVIATION 18.87 • n=107 Participants
|
76.83 units on a scale
STANDARD_DEVIATION 18.96 • n=206 Participants
|
|
Bladder diary: # micturations
|
9.03 Micturation episodes per 24 hour period
STANDARD_DEVIATION 2.21 • n=99 Participants
|
9.23 Micturation episodes per 24 hour period
STANDARD_DEVIATION 3.31 • n=107 Participants
|
9.14 Micturation episodes per 24 hour period
STANDARD_DEVIATION 2.83 • n=206 Participants
|
|
Bladder diary: # leaks
|
1.33 Number of leaks per 24-hour period
STANDARD_DEVIATION 2.45 • n=99 Participants
|
1.72 Number of leaks per 24-hour period
STANDARD_DEVIATION 1.23 • n=107 Participants
|
1.55 Number of leaks per 24-hour period
STANDARD_DEVIATION 1.82 • n=206 Participants
|
|
Bladder diary: # nocturia episodes
|
2.23 Number of nocturia episodes per 24 hours
STANDARD_DEVIATION 1.69 • n=99 Participants
|
1.90 Number of nocturia episodes per 24 hours
STANDARD_DEVIATION 1.09 • n=107 Participants
|
2.04 Number of nocturia episodes per 24 hours
STANDARD_DEVIATION 1.36 • n=206 Participants
|
|
Patient perception of Bladder Condition (PBC/PPBC)
Causes me (some) moderate problems
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Patient perception of Bladder Condition (PBC/PPBC)
Causes me severe problems
|
4 participants
n=99 Participants
|
7 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Patient perception of Bladder Condition (PBC/PPBC)
Causes me many severe problems
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Patient Perception of Intensity of Urgency Scale (PPIUS)
Mild Urgency
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Patient Perception of Intensity of Urgency Scale (PPIUS)
Moderate Urgency
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Patient Perception of Intensity of Urgency Scale (PPIUS)
Moderate-Severe
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Patient Perception of Intensity of Urgency Scale (PPIUS)
Severe Urgency
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Solifenacin Succinate (VESIcare)
n=9 Participants
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=12 Participants
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
|---|---|---|
|
Number of Micturations Per 24 Hour Period
Baseline
|
8.78 Number of micturations per 24 hours
Standard Deviation 2.18
|
9.19 Number of micturations per 24 hours
Standard Deviation 3.46
|
|
Number of Micturations Per 24 Hour Period
Endpoint (12 weeks)
|
8.00 Number of micturations per 24 hours
Standard Deviation 3.36
|
8.94 Number of micturations per 24 hours
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: 12 weeksThis 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.
Outcome measures
| Measure |
Solifenacin Succinate (VESIcare)
n=9 Participants
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=12 Participants
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
|---|---|---|
|
Number of Urinary Incontinence Episodes Per 24 Hour Period
Baseline
|
1.48 Number of incontinence episodes/24 hours
Standard Deviation 2.56
|
1.78 Number of incontinence episodes/24 hours
Standard Deviation 1.27
|
|
Number of Urinary Incontinence Episodes Per 24 Hour Period
Endpoint (12 weeks)
|
0.30 Number of incontinence episodes/24 hours
Standard Deviation 0.31
|
1.61 Number of incontinence episodes/24 hours
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 12 weeksTo 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).
Outcome measures
| Measure |
Solifenacin Succinate (VESIcare)
n=9 Participants
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=12 Participants
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total
Baseline
|
25.00 units on a scale
Standard Deviation 9.70
|
25.67 units on a scale
Standard Deviation 12.26
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total
Endpoint (12 weeks)
|
21.67 units on a scale
Standard Deviation 9.59
|
25.75 units on a scale
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: 12 weeksThis 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.
Outcome measures
| Measure |
Solifenacin Succinate (VESIcare)
n=9 Participants
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=12 Participants
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
|---|---|---|
|
Parkinson's Disease Quality of Life Scale (PDQOL)
Baseline
|
125.00 units on a scale
Standard Deviation 20.95
|
114.50 units on a scale
Standard Deviation 10.73
|
|
Parkinson's Disease Quality of Life Scale (PDQOL)
Endpoint (12 weeks)
|
116.00 units on a scale
Standard Deviation 26.42
|
112.92 units on a scale
Standard Deviation 17.19
|
SECONDARY outcome
Timeframe: 12 weeksTo examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity
Outcome measures
| Measure |
Solifenacin Succinate (VESIcare)
n=9 Participants
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=12 Participants
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
|---|---|---|
|
Number of Nocturia Episodes Per 24 Hour Period
Baseline
|
2.48 Number of nocturia episodes per 24 hours
Standard Deviation 1.59
|
1.92 Number of nocturia episodes per 24 hours
Standard Deviation 1.14
|
|
Number of Nocturia Episodes Per 24 Hour Period
Endpoint (12 weeks)
|
2.04 Number of nocturia episodes per 24 hours
Standard Deviation 1.96
|
1.78 Number of nocturia episodes per 24 hours
Standard Deviation 0.88
|
Adverse Events
Solifenacin Succinate (VESIcare)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Solifenacin Succinate (VESIcare)
n=10 participants at risk
solifenacin succinate (VESIcare): up to 10mg every day orally
|
Placebo
n=13 participants at risk
placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Xerostomia
|
20.0%
2/10 • Number of events 2
|
0.00%
0/13
|
|
Renal and urinary disorders
urinary retention
|
10.0%
1/10 • Number of events 1
|
0.00%
0/13
|
Additional Information
Theresa Zesiewicz, MD, Professor of Neurology
University of South Florida
Phone: 813-974-5909
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place