Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Condition: Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Intervention: Solifenacin
Intervention description: Women presenting with UUI symptoms receive 5 to 10 milligrams (mg) of daily solifenacin for up to 16 weeks
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Urge Urinary Incontinence; Vesicare; Urinary Incontinence; Sexual function; solifenacin

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.
    

Eligibility 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