Incontinence, Post-micturition Incontinence
Conditions
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.
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
Interventions
DRUGsolifenacin
patient will receive solifenacin 5mg daily or placebo daily
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solifenacin patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily | 58 |
| Placebo patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily | 60 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Solifenacin | Placebo |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 13.9 | 55.4 years STANDARD_DEVIATION 14.2 | 48.2 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 56 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| post void dribbling episodes per day | 3.25 post void dribbling episodes STANDARD_DEVIATION 2.76 | 3.38 post void dribbling episodes STANDARD_DEVIATION 2.84 | 3.11 post void dribbling episodes STANDARD_DEVIATION 2.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 103 Participants | 51 Participants | 52 Participants |
| Region of Enrollment United States | 118 participants | 58 participants | 60 participants |
| Sex: Female, Male Female | 118 Participants | 58 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| urgency episodes per day | 2.76 urgency episodes per day STANDARD_DEVIATION 3.9 | 2.64 urgency episodes per day STANDARD_DEVIATION 2.84 | 2.87 urgency episodes per day STANDARD_DEVIATION 4.73 |
| voids per day | 9.39 voids per day STANDARD_DEVIATION 4.48 | 9.55 voids per day STANDARD_DEVIATION 5.2 | 9.23 voids per day STANDARD_DEVIATION 3.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 58 | 16 / 60 |
| serious Total, serious adverse events | 2 / 58 | 0 / 60 |
Outcome results
Primary
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
Population: one subject was excluded from analysis because of missing baseline data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solifenacin | The Percent Reduction in Post Void Dribbling Episodes (Events) | 59.8 percent reduction |
| Placebo | The Percent Reduction in Post Void Dribbling Episodes (Events) | 42.1 percent reduction |
Comparison: 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.p-value: 0.113595% CI: [-4.3, 39.7]Mixed Models Analysis
Secondary
Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
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
Population: one subject was excluded from analysis because of missing baseline data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solifenacin | Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions) | -35.12 change in score |
| Placebo | Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions) | -28.84 change in score |
Comparison: the difference in change between the groups was measuredp-value: 0.4495% CI: [-17.5, 6.2]ANCOVA
Secondary
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
Population: one study subject was excluded form analysis due to missing baseline data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solifenacin | the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes | 69.8 percent |
| Placebo | the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes | 55.5 percent |
p-value: 0.091995% CI: [-2.3, 30.8]Regression, Logistic