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The Effect of Solifenacin on Post Void Dribbling in Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470001
First Posted: November 10, 2011
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
November 2, 2011
November 10, 2011
September 28, 2016
August 23, 2017
August 23, 2017
November 2011
September 2015   (Final data collection date for primary outcome measure)
The Percent Reduction in Post Void Dribbling Episodes (Events) [ Time Frame: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12 ]
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 ]
Complete list of historical versions of study NCT01470001 on ClinicalTrials.gov Archive Site
  • the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes [ Time Frame: 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) [ Time Frame: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment ]

    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).

  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Post-micturition Incontinence
  • Incontinence
Drug: solifenacin
patient will receive solifenacin 5mg daily or placebo daily
Other Name: vesicare
  • Active Comparator: solifenacin
    patients in this arm will receive drug
    Intervention: Drug: solifenacin
  • Placebo Comparator: placebo
    patients is this arm will receive placebo
    Intervention: Drug: solifenacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
September 2015
September 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 89 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01470001
2011-0513
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Tova S Ablove, MD University of Wisconsin, Madison
University of Wisconsin, Madison
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP