CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 138 enrolled
Drug / intervention
Solifenacindrug
Likely dose
Solifenacin 10 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01559389
NCT01559389Phase 4Completed

Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Loyola University·interventional·Posted Mar 21, 2012·Updated Dec 2, 2019

In Brief

A Phase 4 clinical trial evaluating Solifenacin for Urge Urinary Incontinence. Completed, enrolled 138 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2012
Enrollment StartMar 9, 2012
Primary CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14.3 years ago

Interventions

Solifenacindrug

Women presenting with UUI symptoms receive 5 to 10 milligrams (mg) of daily solifenacin for up to 16 weeks