Completed

IIMPACTIncontinence & Intimate Partners: Assessing the Contribution of Treatment

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What is being tested

Solifenacin

Drug
Who is being recruted

Urogenital Diseases+9

+ Female Urogenital Diseases and Pregnancy Complications

+ Signs and Symptoms

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 4
Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorLoyola University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 9, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleIncontinence & Intimate Partners: Assessing the Contribution of Treatment
Principal SponsorLoyola University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

138 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Incontinence, UrgeLower Urinary Tract Symptoms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Loyola University Medical Center

Maywood, United StatesOpen Loyola University Medical Center in Google Maps
CompletedOne Study Center