Skip to content

Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01559389
Acronym
IIMPACT
Enrollment
138
Registered
2012-03-21
Start date
2012-03-09
Completion date
2017-06-29
Last updated
2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urge Urinary Incontinence

Keywords

Urge Urinary Incontinence, Vesicare, Urinary Incontinence, Sexual function, solifenacin

Brief 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.

Detailed description

Chronic illness places emotional, physical, and financial burdens upon both the patient and her partner and can be a significant source of stress in a relationship. The symptoms of UUI inherently pose greater social challenges than those faced by women other forms of pelvic floor disorders. For example, women with UUI may avoid social situations due to fear of having an accident or may be reluctant to participate in activities during which it may be difficult to find a bathroom. The resulting social isolation impacts both members of the dyad and may serve as a source of relationship discord. Changes in sexual function and perceived intimacy, including non-intercourse intimacy, as well as communication may be new sources of stress in a previously healthy relationship or may serve to amplify pre-existing relationship problems. Sexual function is another area in which UUI may cause a negative impact. Studies of coital incontinence among incontinent clinic populations report prevalence ranging from 10%-56% with a median of 22%. The prevalence of coital incontinence may be related to the type of incontinence as well as the severity of symptoms. Stress incontinence has been associated with leakage of urine during intercourse, while detrusor instability and urge incontinence have been correlated with leakage during orgasm. A cross-sectional study of women with UUI and urinary incontinence found that among women reporting low sexual desire, stress incontinence was common (47%), while 46% of women reporting orgasmic phase dysfunction reported symptoms of urge incontinence. Qualitative data corroborates the negative impact of UUI on dyadic and sexual relations. Another mechanism by which UUI may affect satisfaction with dyadic relations is through depressive symptomatology. Urinary incontinence is associated with a decrease in overall health-related quality of life and is positively correlated with depression, anxiety, and stress. Studies of other chronic illnesses demonstrate a correlation between the patient's level of depression and that of their spouse; level of depression shows an inverse relationship with degree of satisfaction with the relationship. One of the two studies in the published literature that use quantitative methods to evaluate the impact of urodynamic stress incontinence and detrusor overactivity on the marital relationship concluded that both sexual function and marital relationships are negatively affected by incontinence. This study, like others, is based upon the perspective of the female partner. A recent study of Swedish women with urinary incontinence and urgency is the only study which includes the perspective of the male partner to examine the impact of UUI on the relationship. It concludes that, Female urinary incontinence, urgency and frequency significantly impair the quality of life in both younger and older women, and also have negative effects on the partner relationship and the partner's life. The perspective of intimate partners of women with UUI and other forms of PFD is largely missing from the literature. Any analysis of the role of UUI in intimate partner relationships is incomplete without this perspective.

Interventions

DRUGSolifenacin

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

Sponsors

Astellas Pharma US, Inc.
CollaboratorINDUSTRY
Loyola University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline Sexual Satisfaction Between Matched Female and Male Partners0 WeeksPrior 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.

Secondary

MeasureTime frameDescription
Change in Overall Sexual Satisfaction Among FemalesBaseline and 12-16 weeksFemales 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.
Change in Overall Sexual Satisfaction Among Healthy Male PartnersBaseline and 12-16 weeksHealthy 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.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from March 2012 through July 2016 (52 months) from the Division of Female Pelvic Medicine & Reconstructive Surgery at Loyola University Medical Center.

Participants by arm

ArmCount
Females With UUI
This arm comprises females who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
49
Male Partners
This arm comprises the healthy male partners of the female participants
49
Total98

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject2020

Baseline characteristics

CharacteristicMale PartnersTotalFemales With UUI
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
49 Participants98 Participants49 Participants
Body Mass Index
30 kg/m^2 or more
30 Participants30 Participants
Body Mass Index
Less than 30 kg/m^2
19 Participants19 Participants
Currently Sexually Active
No
13 Participants13 Participants
Currently Sexually Active
Yes
36 Participants36 Participants
Education
At least some college
0 Participants29 Participants29 Participants
Education
High school or less
0 Participants19 Participants19 Participants
Education
Not reported
0 Participants1 Participants1 Participants
General Health
Excellent
8 Participants12 Participants4 Participants
General Health
Fair
8 Participants16 Participants8 Participants
General Health
Good
16 Participants41 Participants25 Participants
General Health
Poor
1 Participants3 Participants2 Participants
General Health
Very Good
16 Participants26 Participants10 Participants
Marital Status
Divorced
1 Participants4 Participants3 Participants
Marital Status
Married
42 Participants84 Participants42 Participants
Marital Status
Single
6 Participants10 Participants4 Participants
Medical History
Arthritis
13 Participants13 Participants0 Participants
Medical History
Cancer
9 Participants9 Participants0 Participants
Medical History
Depression
6 Participants6 Participants0 Participants
Medical History
Diabetes
9 Participants9 Participants0 Participants
Medical History
Erectile dysfunction
13 Participants13 Participants0 Participants
Medical History
Heart disease
6 Participants6 Participants0 Participants
Medical History
Hypertension
16 Participants16 Participants0 Participants
Menstrual Cycle
Not certain
0 Participants2 Participants2 Participants
Menstrual Cycle
Post-menopausal
0 Participants38 Participants38 Participants
Menstrual Cycle
Pre-menopausal
0 Participants9 Participants9 Participants
Prior Surgery
No
22 Participants22 Participants
Prior Surgery
Yes
27 Participants27 Participants
Prior Treatment for Pelvic Floor Disorders
No
29 Participants29 Participants
Prior Treatment for Pelvic Floor Disorders
Yes
20 Participants20 Participants
Prior Treatments for Overactive Bladder Syndrome
No
30 Participants30 Participants
Prior Treatments for Overactive Bladder Syndrome
Yes
19 Participants19 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Black
8 Participants16 Participants8 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants7 Participants4 Participants
Race/Ethnicity, Customized
Other
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
White
36 Participants73 Participants37 Participants
Region of Enrollment
United States
49 participants98 participants49 participants
Sex: Female, Male
Female
0 Participants49 Participants49 Participants
Sex: Female, Male
Male
49 Participants49 Participants0 Participants
Vaginal Parity
0-1 births
0 Participants8 Participants8 Participants
Vaginal Parity
2 births
0 Participants20 Participants20 Participants
Vaginal Parity
3 births
0 Participants10 Participants10 Participants
Vaginal Parity
4-6 births
0 Participants11 Participants11 Participants
Years with Partner
30 or more years
26 Participants51 Participants25 Participants
Years with Partner
Fewer than 30 years
23 Participants47 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 0
other
Total, other adverse events
0 / 490 / 0
serious
Total, serious adverse events
0 / 490 / 0

Outcome results

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.

Time frame: 0 Weeks

ArmMeasureValue (MEAN)Dispersion
Females With UUIBaseline Sexual Satisfaction Between Matched Female and Male Partners4.2 score on a scaleStandard Deviation 2.3
Male PartnersBaseline Sexual Satisfaction Between Matched Female and Male Partners4.8 score on a scaleStandard Deviation 2.4
Comparison: The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partnersp-value: 0.1695% CI: [-1.23, 0.21]t-test, 2 sided
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.

Time frame: Baseline and 12-16 weeks

Population: The analysis population comprises 49 female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms

ArmMeasureValue (MEDIAN)
Females With UUIChange in Overall Sexual Satisfaction Among Females-0.5 score on a scale
Male PartnersChange in Overall Sexual Satisfaction Among Females0 score on a scale
Comparison: The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.p-value: 0.003Wilcoxon (Mann-Whitney)
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.

Time frame: Baseline and 12-16 weeks

Population: The analysis population comprises the 49 male partners of the female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms

ArmMeasureValue (MEDIAN)
Females With UUIChange in Overall Sexual Satisfaction Among Healthy Male Partners0 score on a scale
Male PartnersChange in Overall Sexual Satisfaction Among Healthy Male Partners0 score on a scale
Comparison: The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacinp-value: 0.37Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026