The Effect of Solifenacin on Post Void Dribbling in Women

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT01470001
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.

Condition or Disease	Intervention/Treatment	Phase
Post-micturition Incontinence; Incontinence	Drug: solifenacin	N/A

Detailed Description

This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.

Secondary endpoints will include:

1. The % of patients with at least a 50% reduction in post void dribbling episodes.

2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.

We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: solifenacin patients in this arm will receive drug	Drug: solifenacin; patient will receive solifenacin 5mg daily or placebo daily; Other Names: vesicare
Placebo Comparator: placebo patients is this arm will receive placebo	Drug: solifenacin; patient will receive solifenacin 5mg daily or placebo daily; Other Names: vesicare

Outcome Measures

Primary Outcome Measures

1. The Percent Reduction in Post Void Dribbling Episodes (Events) [outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12]

Secondary Outcome Measures

1. the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes [outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12]

2. Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions) [outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Women between the ages of 18 and 89

2. Incontinence in the form of post void dribbling that occurs at least twice weekly.

Exclusion Criteria:

1. Severe renal or hepatic disease.

2. Active urinary tract infection.

3. Glaucoma.

4. Stress incontinence as the only incontinence symptom

5. Urge incontinence as the only incontinence symptom

6. Chronic severe constipation.

7. History of bladder cancer.

8. Known or suspected hypersensitivity to anticholinergics.

9. Any clinical condition that would not allow safe completion of the study.

10. Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.

11. Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.

12. Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UW Hospital and Clinics	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Tova S Ablove, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01470001
• Other Study ID Numbers: 2011-0513
• First Posted: Nov 10, 2011
• Last Update Posted: Aug 23, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Solifenacin Succinate

Study Results

Participant Flow

Arm/Group Title	Treatment	Placebo
Arm/Group Description	study subjects who received solifenacin 5mg daily	study subjects who received placebo daily
Period Title: Overall Study
STARTED	58	60
COMPLETED	53	58
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Solifenacin	Placebo	Total
Arm/Group Description	patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily	patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily	Total of all reporting groups
Overall Participants	58	60	118
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (14.2)	48.2 (12.8)	51.8 (13.9)
Sex: Female, Male (Count of Participants)
Female	58 100%	60 100%	118 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.7%	1 1.7%	2 1.7%
Not Hispanic or Latino	56 96.6%	59 98.3%	115 97.5%
Unknown or Not Reported	1 1.7%	0 0%	1 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.7%	0 0%	1 0.8%
Asian	0 0%	1 1.7%	1 0.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 3.4%	5 8.3%	7 5.9%
White	51 87.9%	52 86.7%	103 87.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 6.9%	2 3.3%	6 5.1%
Region of Enrollment (participants) [Number]
United States	58 100%	60 100%	118 100%
post void dribbling episodes per day (post void dribbling episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [post void dribbling episodes]	3.38 (2.84)	3.11 (2.65)	3.25 (2.76)
voids per day (voids per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [voids per day]	9.55 (5.20)	9.23 (3.68)	9.39 (4.48)
urgency episodes per day (urgency episodes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [urgency episodes per day]	2.64 (2.84)	2.87 (4.73)	2.76 (3.90)

Outcome Measures

1. Primary Outcome

Title	The Percent Reduction in Post Void Dribbling Episodes (Events)
Time Frame	outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12

Outcome Measure Data

Analysis Population Description

one subject was excluded from analysis because of missing baseline data

Arm/Group Title	Solifenacin	Placebo
Arm/Group Description	patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily	patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily
Measure Participants	58	59
Mean (Full Range) [percent reduction]	59.8	42.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin, Placebo
	Comments	A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.1135
	Comments
	Method	Mixed Models Analysis
	Comments	mixed model with repeated measurements
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	17.7
	Confidence Interval	(2-Sided) 95%; -4.3 to 39.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes
Time Frame	outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12

Outcome Measure Data

Analysis Population Description

one study subject was excluded form analysis due to missing baseline data

Arm/Group Title	Solifenacin	Placebo
Arm/Group Description	patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily	patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily
Measure Participants	58	59
Number [percent]	69.8	55.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0919
	Comments
	Method	Regression, Logistic
	Comments	logistic regression with repeated measurements
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.3
	Confidence Interval	(2-Sided) 95%; -2.3 to 30.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
Description	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).
Time Frame	outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment

Outcome Measure Data

Analysis Population Description

one subject was excluded from analysis because of missing baseline data

Arm/Group Title	Solifenacin	Placebo
Arm/Group Description	patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily	patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily
Measure Participants	58	59
Mean (Full Range) [change in score]	-35.12	-28.84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin, Placebo
	Comments	the difference in change between the groups was measured
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	p value was adjusted for age.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -17.5 to 6.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	we calculated the estimated difference in change between the placebo and treatment groups.

Adverse Events

Arm/Group Title	Solifenacin		Placebo
Arm/Group Description	patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily		patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily
All Cause Mortality
	Solifenacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Solifenacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/58 (3.4%)		0/60 (0%)
Gastrointestinal disorders
small bowel obstruction	1/58 (1.7%)	1	0/60 (0%)	0
Musculoskeletal and connective tissue disorders
elective surgery	1/58 (1.7%)	1	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Solifenacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/58 (39.7%)		16/60 (26.7%)
Eye disorders
blurry eyes	2/58 (3.4%)		0/60 (0%)
dry eyes	4/58 (6.9%)		0/60 (0%)
Gastrointestinal disorders
constipation	2/58 (3.4%)		1/60 (1.7%)
dry mouth	4/58 (6.9%)		2/60 (3.3%)
diarrhea	2/58 (3.4%)		4/60 (6.7%)
upset stomach	3/58 (5.2%)		1/60 (1.7%)
nausea	3/58 (5.2%)		2/60 (3.3%)
vomiting	4/58 (6.9%)		1/60 (1.7%)
Infections and infestations
cold	9/58 (15.5%)		4/60 (6.7%)
pneumonia	2/58 (3.4%)		0/60 (0%)
UTI	2/58 (3.4%)		1/60 (1.7%)
Nervous system disorders
headache	2/58 (3.4%)		3/60 (5%)
Renal and urinary disorders
worsening incontinence	0/58 (0%)		3/60 (5%)
increased urinary frequency	3/58 (5.2%)		1/60 (1.7%)
Reproductive system and breast disorders
hot flashes	0/58 (0%)		2/60 (3.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.