NCT01559389: IIMPACT

Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Completed Phase 4 Results posted Last updated 2 December 2019

What this trial tests

Phase 4 trial testing Solifenacin in Urge Urinary Incontinence in 138 participants. Completed in 29 June 2017.

Timeline

9 March 2012

Primary endpoint
29 June 2017

29 June 2017

Quick facts

Lead sponsor	Loyola University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	138
Start date	9 March 2012
Primary completion	29 June 2017
Estimated completion	29 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Solifenacin (SOLIFENACIN) — full drug profile →

Conditions studied

• Urge Urinary Incontinence — all drugs for Urge Urinary Incontinence →

Sponsor

Loyola University

Who can join

18 and older, any sex, with Urge Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline Sexual Satisfaction Between Matched Female and Male Partners Primary · 0 Weeks

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.

Group	Value	95% CI
Females With UUI	4.2	± 2.3
Male Partners	4.8	± 2.4

Change in Overall Sexual Satisfaction Among Females Secondary · Baseline and 12-16 weeks

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.

Group	Value	95% CI
Responder	-0.5	-1 – 0
Non-Responder	0	0 – 1

Change in Overall Sexual Satisfaction Among Healthy Male Partners Secondary · Baseline and 12-16 weeks

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

Group	Value	95% CI
Male Partners of Female Responders	0	0 – 0
Male Partners of Female Non-Responders	0	-1 – 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.