Clinical trial NCT01559389: Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Official title: Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urge Urinary Incontinence
Keywords: Urge Urinary Incontinence
Vesicare
Urinary Incontinence
Sexual function
solifenacin
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2012-03-21
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Chronic illness places emotional, physical, and financial burdens upon both the patient and her partner and can be a significant source of stress in a relationship. The symptoms of UUI inherently pose greater social challenges than those faced by women other forms of pelvic floor disorders. For example, women with UUI may avoid social situations due to fear of having an accident or may be reluctant to participate in activities during which it may be difficult to find a bathroom. The resulting social isolation impacts both members of the dyad and may serve as a source of relationship discord. Changes in sexual function and perceived intimacy, including non-intercourse intimacy, as well as communication may be new sources of stress in a previously healthy relationship or may serve to amplify pre-existing relationship problems.

Sexual function is another area in which UUI may cause a negative impact. Studies of coital incontinence among incontinent clinic populations report prevalence ranging from 10%-56% with a median of 22%. The prevalence of coital incontinence may be related to the type of incontinence as well as the severity of symptoms. Stress incontinence has been associated with leakage of urine during intercourse, while detrusor instability and urge incontinence have been correlated with leakage during orgasm. A cross-sectional study of women with UUI and urinary incontinence found that among women reporting low sexual desire, stress incontinence was common (47%), while 46% of women reporting orgasmic phase dysfunction reported symptoms of urge incontinence. Qualitative data corroborates the negative impact of UUI on dyadic and sexual relations.

Another mechanism by which UUI may affect satisfaction with dyadic relations is through depressive symptomatology. Urinary incontinence is associated with a decrease in overall health-related quality of life and is positively correlated with depression, anxiety, and stress. Studies of other chronic illnesses demonstrate a correlation between the patient's level of depression and that of their spouse; level of depression shows an inverse relationship with degree of satisfaction with the relationship.

One of the two studies in the published literature that use quantitative methods to evaluate the impact of urodynamic stress incontinence and detrusor overactivity on the marital relationship concluded that both sexual function and marital relationships are negatively affected by incontinence. This study, like others, is based upon the perspective of the female partner. A recent study of Swedish women with urinary incontinence and urgency is the only study which includes the perspective of the male partner to examine the impact of UUI on the relationship. It concludes that, "Female urinary incontinence, urgency and frequency significantly impair the quality of life in both younger and older women, and also have negative effects on the partner relationship and the partner's life".

The perspective of intimate partners of women with UUI and other forms of PFD is largely missing from the literature. Any analysis of the role of UUI in intimate partner relationships is incomplete without this perspective.

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

Primary outcomes:
measure: Baseline Sexual Satisfaction Between Matched Female and Male Partners
timeFrame: 0 Weeks
Secondary outcomes:
measure: Change in Overall Sexual Satisfaction Among Females
timeFrame: Baseline and 12-16 weeks
measure: Change in Overall Sexual Satisfaction Among Healthy Male Partners
timeFrame: Baseline and 12-16 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Elizabeth Meuller, MD
role: PRINCIPAL_INVESTIGATOR
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