Trial Outcomes & Findings for The Effect of Solifenacin on Post Void Dribbling in Women (NCT NCT01470001)
NCT ID: NCT01470001
Last Updated: 2017-08-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
Results posted on
2017-08-23
Participant Flow
Participant milestones
| Measure |
Treatment
study subjects who received solifenacin 5mg daily
|
Placebo
study subjects who received placebo daily
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
53
|
58
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Treatment
study subjects who received solifenacin 5mg daily
|
Placebo
study subjects who received placebo daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
The Effect of Solifenacin on Post Void Dribbling in Women
Baseline characteristics by cohort
| Measure |
Solifenacin
n=58 Participants
patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Placebo
n=60 Participants
patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
60 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
post void dribbling episodes per day
|
3.38 post void dribbling episodes
STANDARD_DEVIATION 2.84 • n=5 Participants
|
3.11 post void dribbling episodes
STANDARD_DEVIATION 2.65 • n=7 Participants
|
3.25 post void dribbling episodes
STANDARD_DEVIATION 2.76 • n=5 Participants
|
|
voids per day
|
9.55 voids per day
STANDARD_DEVIATION 5.20 • n=5 Participants
|
9.23 voids per day
STANDARD_DEVIATION 3.68 • n=7 Participants
|
9.39 voids per day
STANDARD_DEVIATION 4.48 • n=5 Participants
|
|
urgency episodes per day
|
2.64 urgency episodes per day
STANDARD_DEVIATION 2.84 • n=5 Participants
|
2.87 urgency episodes per day
STANDARD_DEVIATION 4.73 • n=7 Participants
|
2.76 urgency episodes per day
STANDARD_DEVIATION 3.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12Population: one subject was excluded from analysis because of missing baseline data
Outcome measures
| Measure |
Solifenacin
n=58 Participants
patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Placebo
n=59 Participants
patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
|---|---|---|
|
The Percent Reduction in Post Void Dribbling Episodes (Events)
|
59.8 percent reduction
Interval 44.0 to 75.7
|
42.1 percent reduction
Interval 26.8 to 57.4
|
SECONDARY outcome
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12Population: one study subject was excluded form analysis due to missing baseline data
Outcome measures
| Measure |
Solifenacin
n=58 Participants
patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Placebo
n=59 Participants
patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
|---|---|---|
|
the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes
|
69.8 percent
|
55.5 percent
|
SECONDARY outcome
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatmentPopulation: one subject was excluded from analysis because of missing baseline data
The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect. The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease).
Outcome measures
| Measure |
Solifenacin
n=58 Participants
patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Placebo
n=59 Participants
patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
|---|---|---|
|
Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
|
-35.12 change in score
Interval -130.0 to 32.57
|
-28.84 change in score
Interval -130.0 to 65.15
|
Adverse Events
Solifenacin
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Solifenacin
n=58 participants at risk
patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Placebo
n=60 participants at risk
patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
|---|---|---|
|
Gastrointestinal disorders
small bowel obstruction
|
1.7%
1/58 • Number of events 1
|
0.00%
0/60
|
|
Musculoskeletal and connective tissue disorders
elective surgery
|
1.7%
1/58 • Number of events 1
|
0.00%
0/60
|
Other adverse events
| Measure |
Solifenacin
n=58 participants at risk
patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
Placebo
n=60 participants at risk
patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily
|
|---|---|---|
|
Eye disorders
blurry eyes
|
3.4%
2/58
|
0.00%
0/60
|
|
Eye disorders
dry eyes
|
6.9%
4/58
|
0.00%
0/60
|
|
Gastrointestinal disorders
constipation
|
3.4%
2/58
|
1.7%
1/60
|
|
Gastrointestinal disorders
dry mouth
|
6.9%
4/58
|
3.3%
2/60
|
|
Gastrointestinal disorders
diarrhea
|
3.4%
2/58
|
6.7%
4/60
|
|
Gastrointestinal disorders
upset stomach
|
5.2%
3/58
|
1.7%
1/60
|
|
Gastrointestinal disorders
nausea
|
5.2%
3/58
|
3.3%
2/60
|
|
Gastrointestinal disorders
vomiting
|
6.9%
4/58
|
1.7%
1/60
|
|
Infections and infestations
cold
|
15.5%
9/58
|
6.7%
4/60
|
|
Infections and infestations
pneumonia
|
3.4%
2/58
|
0.00%
0/60
|
|
Infections and infestations
UTI
|
3.4%
2/58
|
1.7%
1/60
|
|
Nervous system disorders
headache
|
3.4%
2/58
|
5.0%
3/60
|
|
Renal and urinary disorders
worsening incontinence
|
0.00%
0/58
|
5.0%
3/60
|
|
Renal and urinary disorders
increased urinary frequency
|
5.2%
3/58
|
1.7%
1/60
|
|
Reproductive system and breast disorders
hot flashes
|
0.00%
0/58
|
3.3%
2/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place