Urge Urinary Incontinence Clinical Trial
— IIMPACTOfficial title:
Incontinence & Intimate Partners: Assessing the Contribution of Treatment
NCT number | NCT01559389 |
Other study ID # | 203952 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 9, 2012 |
Est. completion date | June 29, 2017 |
Verified date | November 2019 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | June 29, 2017 |
Est. primary completion date | June 29, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Loyola University Medical Center | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University | Astellas Pharma US, Inc. |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline Sexual Satisfaction Between Matched Female and Male Partners | Prior to beginning treatment with solifenacin, females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Their male partners also complete the GRISS at the baseline visit. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. | 0 Weeks | |
Secondary | Change in Overall Sexual Satisfaction Among Females | Females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) at baseline (0 weeks) and after 12-16 weeks of treatment with solifenacin. For this outcome, the baseline score is subtracted from the follow-up score and this change score is compared between those who respond and do not respond to treatment with solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. | Baseline and 12-16 weeks | |
Secondary | Change in Overall Sexual Satisfaction Among Healthy Male Partners | Healthy male partners of female participants complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) survey. For this outcome, their baseline score is subtracted from their follow-up score which is collected after their female partner completes approximately 12-16 weeks of solifenacin treatment for UUI symptoms. This change score is compared between male partners of female participants who respond to solifenacin versus male partners of female participants who do not respond to solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. | Baseline and 12-16 weeks |
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