The Effect of Solifenacin on Post Void Dribbling in Women

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Solifenacin Succinate

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.