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NCT01559389 · ClinicalTrials.gov registry record · Phase 4
Incontinence & Intimate Partners: Assessing the Contribution of Treatment
A Phase 4 study, sponsored by Loyola University.
- Completed
- Registry status
- Phase 4
- Development phase
- 138
- Enrollment target
NCT01559389 is a Phase 4 study that has completed, run by Loyola University. The registered enrollment target is 138 participants.
The verdict
NCT01559389, a Phase 4 study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 138 participants
- Enrollment target
Study 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.
Interventions
- DRUG Solifenacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2012-03-09 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01559389
The ClinicalTrials.gov registry entry for NCT01559389 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Solifenacin is the first listed.
NCT01559389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01559389 about?
NCT01559389 is a clinical study titled "Incontinence & Intimate Partners: Assessing the Contribution of Treatment". 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. T...
What is the current status of trial NCT01559389?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 138 participants. The study started on 2012-03-09. Estimated completion is 2017-06-29.
What interventions are being tested in trial NCT01559389?
The interventions under investigation include: Solifenacin (DRUG).
Who is sponsoring clinical trial NCT01559389?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
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