Incontinence & Intimate Partners: Assessing the Contribution of Treatment

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: All

Summary

Urge urinary incontinence (UUI) is a socially debilitating disease due to its inherently unpredictable nature and sometimes large volumes of urine loss. Women with UUI may experience anxiety over public episodes of incontinence and concerns about odor and, as a result, isolate themselves socially. This isolation affects both partners in the relationship and may be a source of discord. The impact of UUI also moves into personal relationships where fears or actual episodes of incontinence during physical intimacy, including but limited to intercourse, may result in limited interactions and changes in the relationship satisfaction for both partners. Few studies have examined the role of urinary incontinence, particularly UUI, in the dynamics of an intimate partner relationship and none have evaluated the impact of successful UUI treatment.

The long-term goal of our research is to understand the social and emotional impact of pelvic floor disorders, particularly UUI, on the well-being of an intimate relationship. Ultimately, we aim to evaluate the role that successful treatment plays in the alleviation of discord in intimate partner relationships that are affected by UUI and other pelvic floor disorders.

Our objective for this proposal 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. Our rationale for this study is that an 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Loyola University
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Solifenacin Succinate

Criteria

Healthy male partners may volunteer to participate in this study along with their affected female partners. There are no inclusion or exclusion criteria for male partners.

For affected female participants, the following inclusion criteria apply:

• Age ≥ 18 years

• In a relationship with a male partner for at least 3 months

• Not pregnant or planning to become pregnant

• Have a diagnosis of UUI or Mixed Urinary Incontinence (MUI) that is urge predominant based on a 3 day voiding diary

• Are interested in medical management of their symptoms

• Are candidates for solifenacin

• Are able to provide informed consent

• Are able to complete written questionnaires.

For affected female partners, the following exclusion criteria apply:

• Post Voided Residual (PVR) > 200 ml at the initial visit

• History of a significant outflow obstruction

• History of persistent/recurrent Urinary Tract Infection (UTI)

• History of bladder stones

• History of a diagnosis of chronic interstitial cystitis

• History of 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

• History of chronic pelvic pain

• Active psychotic disorder

• Male partner does not speak English

• Declines permission for the study team to recruit their male partner for the study