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

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ClinicalTrials.gov Identifier: NCT01559389
Recruitment Status : Completed
First Posted : March 21, 2012
Results First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Elizabeth Mueller, Loyola University

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.


Condition or disease Intervention/treatment Phase
Urge Urinary Incontinence Drug: Solifenacin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Actual Study Start Date : March 9, 2012
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : June 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Female Partners
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
Drug: Solifenacin
Women presenting with UUI symptoms receive 5 to 10 milligrams (mg) of daily solifenacin for up to 16 weeks
Other Name: Vesicare

No Intervention: Male Partners
This arm comprises healthy male partners



Primary Outcome Measures :
  1. Baseline Sexual Satisfaction Between Matched Female and Male Partners [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Overall Sexual Satisfaction Among Females [ Time Frame: 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.

  2. Change in Overall Sexual Satisfaction Among Healthy Male Partners [ Time Frame: 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 relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559389


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Astellas Pharma US, Inc.
Investigators
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Principal Investigator: Elizabeth Meuller, MD Loyola University
  Study Documents (Full-Text)

Documents provided by Elizabeth Mueller, Loyola University:
Publications:

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Responsible Party: Elizabeth Mueller, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01559389    
Other Study ID Numbers: 203952
First Posted: March 21, 2012    Key Record Dates
Results First Posted: December 2, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

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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
Keywords provided by Elizabeth Mueller, Loyola University:
Urge Urinary Incontinence
Vesicare
Urinary Incontinence
Sexual function
solifenacin
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents