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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: Completed Phase 4 study, sponsored by Loyola University.
NCT01559389 is a Phase 4 study that has completed, run by Loyola University. The registered enrollment target is 138 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- DRUG Solifenacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2012-03-09 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 4 |
What the finished NCT01559389 record still lists
NCT01559389 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Solifenacin is the first listed.
NCT01559389 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01559389's enrollment target sits among peer trials
138 593rd of 2000 higher than 1,407 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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