Status:
COMPLETED
The Effect of Solifenacin on Post Void Dribbling in Women
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Post-micturition Incontinence
Incontinence
Eligibility:
FEMALE
18-89 years
Phase:
NA
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 wil...
Eligibility Criteria
Inclusion
- Women between the ages of 18 and 89
- Incontinence in the form of post void dribbling that occurs at least twice weekly.
Exclusion
- Severe renal or hepatic disease.
- Active urinary tract infection.
- Glaucoma.
- Stress incontinence as the only incontinence symptom
- Urge incontinence as the only incontinence symptom
- Chronic severe constipation.
- History of bladder cancer.
- Known or suspected hypersensitivity to anticholinergics.
- Any clinical condition that would not allow safe completion of the study.
- 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.
- 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.
- Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01470001
Start Date
November 1 2011
End Date
September 1 2015
Last Update
August 23 2017
Active Locations (1)
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1
UW Hospital and Clinics
Madison, Wisconsin, United States, 53792