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Incontinence & Intimate Partners: Assessing the Contribution of Treatment (IIMPACT)

Primary Purpose

Urge Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solifenacin
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urge Urinary Incontinence focused on measuring Urge Urinary Incontinence, Vesicare, Urinary Incontinence, Sexual function, solifenacin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 exclusion criteria apply:

  • Post Voided Residual (PVR) > 200 ml at the initial visit
  • History of a significant outflow obstruction
  • History of persistent/recurrent Urinary Tract Infection (UTI)
  • History of bladder stones
  • History of a diagnosis of chronic interstitial cystitis
  • History of pelvic irradiation
  • Current pelvic malignancy
  • Narrow angle glaucoma
  • Urinary or gastric retention
  • Current use of a tricyclic antidepressant
  • A neurologic diagnosis that could affect bladder function
  • History of chronic pelvic pain
  • Active psychotic disorder
  • Male partner does not speak English
  • Declines permission for the study team to recruit their male partner for the study

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Female Partners

Male Partners

Arm Description

This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms

This arm comprises healthy male partners

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 15, 2012
Last Updated
November 11, 2019
Sponsor
Loyola University
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01559389
Brief Title
Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Acronym
IIMPACT
Official Title
Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 9, 2012 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Urinary Incontinence
Keywords
Urge Urinary Incontinence, Vesicare, Urinary Incontinence, Sexual function, solifenacin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Female Partners
Arm Type
Experimental
Arm Description
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
Arm Title
Male Partners
Arm Type
No Intervention
Arm Description
This arm comprises healthy male partners
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Other Intervention Name(s)
Vesicare
Intervention Description
Women presenting with UUI symptoms receive 5 to 10 milligrams (mg) of daily solifenacin for up to 16 weeks
Primary Outcome Measure Information:
Title
Baseline Sexual Satisfaction Between Matched Female and Male Partners
Description
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
Secondary Outcome Measure Information:
Title
Change in Overall Sexual Satisfaction Among Females
Description
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
Title
Change in Overall Sexual Satisfaction Among Healthy Male Partners
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 exclusion criteria apply: Post Voided Residual (PVR) > 200 ml at the initial visit History of a significant outflow obstruction History of persistent/recurrent Urinary Tract Infection (UTI) History of bladder stones History of a diagnosis of chronic interstitial cystitis History of pelvic irradiation Current pelvic malignancy Narrow angle glaucoma Urinary or gastric retention Current use of a tricyclic antidepressant A neurologic diagnosis that could affect bladder function History of chronic pelvic pain Active psychotic disorder Male partner does not speak English Declines permission for the study team to recruit their male partner for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Meuller, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data
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Incontinence & Intimate Partners: Assessing the Contribution of Treatment

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