The Effect of Solifenacin on Post Void Dribbling in Women

Incontinence Clinical Trial

Official title:

The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470001
• Other study ID #: 2011-0513
• Status: Completed
• Phase: N/A
• First received: November 2, 2011
• Last updated: October 9, 2015
• Start date: November 2011
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 (PVD).

Description:

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

Secondary endpoints will include:

1. The % of patients with at least a 50% reduction in PVD episodes.

2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory (PFDI), 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 (PRC) will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incontinence
• Post Micturition Dribble
• Postvoid Dribbling

Intervention

Drug:
• solifenacin
patient will receive solifenacin 5mg daily or placebo daily

Locations

Country	Name	City	State
United States	UW Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent reduction in post void dribbling episodes (events)		out come measures will be assessed at week 0 (baseline), week 4, week 8, and week 12	No
Secondary	the percent of patients with at least 50% reduction in post void dribbling episodes		out come measures will be assessed at week 0 (baseline), week 4, week 8, and week 12	No
Secondary	patients perspective of the impact of their disease, captured using the pelvic floor distress inventory		out come measures will be assessed at week 0 (baseline), week 4, week 8, and week 12	No