The Effect of Solifenacin on Post Void Dribbling in Women

NCT01470001 | Completed Results DMC

• 1 other identifier: 2011-0513
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-micturition Incontinence; Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

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

Study Arms (2)

solifenacin

ACTIVE COMPARATOR

patients in this arm will receive drug

Drug: solifenacin

placebo

PLACEBO COMPARATOR

patients is this arm will receive placebo

Drug: solifenacin

Interventions

solifenacin DRUG

patient will receive solifenacin 5mg daily or placebo daily

Also known as: vesicare

placebo; solifenacin

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 18 and 89
• Incontinence in the form of post void dribbling that occurs at least twice weekly.

You may not qualify if:

• Severe renal or hepatic disease.
• Active urinary tract infection.
• Glaucoma.
• Stress incontinence as the only incontinence symptom
• Urge incontinence as the only incontinence symptom
• Chronic severe constipation.
• History of bladder cancer.
• Known or suspected hypersensitivity to anticholinergics.
• Any clinical condition that would not allow safe completion of the study.
• 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.
• 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.
• Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr Tova Ablove
• Organization: University at Buffalo

tablove@buffalo.edu

716-878-7138

Study Officials

• Tova S Ablove, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 23, 2017
• Results First Posted: August 23, 2017

Record last verified: 2017-07

Locations

US (1)