Incontinence & Intimate Partners: Assessing the Contribution of Treatment
This trial is active, not recruiting.
|Condition||urge urinary incontinence|
|Collaborator||Astellas Pharma US, Inc.|
|Start date||March 2012|
|End date||March 2017|
|Trial size||69 participants|
|Trial identifier||NCT01559389, 203952|
Study the quality of the relationship in couples affected by Urge Urinary Incontinence (UUI) and identify how treatment may improve the relationship.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
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
The impact of successful treatment of UUI on the relationship.
time frame: 12 weeks
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
|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.|
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