Overview

This trial is active, not recruiting.

Condition urge urinary incontinence
Treatment solifenacin succinate
Sponsor Loyola University
Collaborator Astellas Pharma US, Inc.
Start date March 2012
End date March 2017
Trial size 69 participants
Trial identifier NCT01559389, 203952

Summary

Study the quality of the relationship in couples affected by Urge Urinary Incontinence (UUI) and identify how treatment may improve the relationship.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
Open Label
solifenacin succinate Vesicare
5 mg daily up to 10 mg daily

Primary Outcomes

Measure
Levels of relationship satisfaction and sexual function among couples with the female partner having primarily: UUI symptoms and mixed urinary incontinence (urge predominant).
time frame: 12 Weeks

Secondary Outcomes

Measure
The impact of successful treatment of UUI on the relationship.
time frame: 12 weeks

Eligibility Criteria

Female participants from 18 years up to 89 years old.

Inclusion Criteria: - Women will eligible for inclusion in the study if they are: - Age ≥ 18 years, and - In a relationship with a male partner for at least 3 months, and - Not pregnant (pregnancy test will be done at study enrollment) or planning to become pregnant, and - Have a diagnosis of UUI or Mixed Urinary Incontinence, urge predominant, based upon a 3 day voiding diary, and - Are interested in medical management of their symptoms and are candidates for Vesicare, and - Able to provide informed consent and complete the written questionnaires. Exclusion Criteria: - Post Voided Residual > 200 ml at initial visit - Significant outflow obstruction - Persistent/recurrent Urinary Tract Infection - Bladder stones - A diagnosis of chronic interstitial cystitis - Undergone pelvic irradiation - Current pelvic malignancy - Narrow angle glaucoma - Urinary or gastric retention - Current use of a tricyclic antidepressant - A neurologic diagnosis that could affect bladder function (MS) - A diagnosis of chronic pelvic pain - An active psychotic disorder - Or their partner is non-English speaking - Decline permission for the study team to approach their partner regarding participation

Additional Information

Official title Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Principal investigator Elizabeth Meuller, MD
Description The importance of this study is to characterize, using validated, quantifiable methods the quality of the relationship in couples affected by UUI and to identify the role that treatment plays in improving this relationship. Our central hypothesis is that UUI has a negative impact upon the emotional and physical well-being of a relationship and that effective treatment will result in improvement in areas of the relationship that have been detrimentally affected by UUI. Understanding of UUI in the context of a couple, particularly from the perspective of the male partner, will improve our ability to holistically treat UUI, thus improving patient outcomes and satisfaction.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Loyola University.