The Effect of Solifenacin on Post Void Dribbling in Women

Launched by UNIVERSITY OF WISCONSIN, MADISON · Nov 8, 2011

Keywords

ClinConnect Summary

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 e...

Gender

FEMALE

Eligibility criteria

• 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.