The Effect of Solifenacin on Post Void Dribbling in Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01470001
First received: November 2, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention
Postvoid Dribbling
Incontinence
Post Micturition Dribble
Drug: solifenacin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The percent reduction in post void dribbling episodes (events) [ Time Frame: out come measures will be assessed at week 0 (baseline), week 4, week 8, and week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the percent of patients with at least 50% reduction in post void dribbling episodes [ Time Frame: out come measures will be assessed at week 0 (baseline), week 4, week 8, and week 12 ] [ Designated as safety issue: No ]
  • patients perspective of the impact of their disease, captured using the pelvic floor distress inventory [ Time Frame: out come measures will be assessed at week 0 (baseline), week 4, week 8, and week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: solifenacin
patients in this arm will receive drug
Drug: solifenacin
patient will receive solifenacin 5mg daily or placebo daily
Other Name: vesicare
Placebo Comparator: placebo
patients is this arm will receive placebo
Drug: solifenacin
patient will receive solifenacin 5mg daily or placebo daily
Other Name: vesicare

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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), IUD - intrauterine device, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470001

Contacts
Contact: Tova S Ablove, MD 608/263-5573 tsablove@wisc.edu

Locations
United States, Wisconsin
UW Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Tova S Ablove, MD    608-263-5573    tsablove@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Tova S Ablove, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01470001     History of Changes
Other Study ID Numbers: 2011-0513
Study First Received: November 2, 2011
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014