The Effect of Solifenacin on Post Void Dribbling in Women

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

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.

Study Overview

• Status: Completed
• Conditions: Incontinence; Post-micturition Incontinence
• Intervention / Treatment: Drug: solifenacin

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

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: solifenacin; patients in this arm will receive drug	Drug: solifenacin; patient will receive solifenacin 5mg daily or placebo daily; Other Names: vesicare
Placebo Comparator: placebo; patients is this arm will receive placebo	Drug: solifenacin; patient will receive solifenacin 5mg daily or placebo daily; Other Names: vesicare

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Tova S Ablove, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 2, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 10, 2011

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: 2011-0513