Incontinence & Intimate Partners: Assessing the Contribution of Treatment

NCT01559389 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 203952
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Urinary Incontinence

Keywords

Urge Urinary Incontinence; Vesicare; Urinary Incontinence; Sexual function; solifenacin

Outcome Measures

Primary Outcomes (1)

• 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.

  0 Weeks

Secondary Outcomes (2)

• Change in Overall Sexual Satisfaction Among Females

  Baseline and 12-16 weeks

• Change in Overall Sexual Satisfaction Among Healthy Male Partners

  Baseline and 12-16 weeks

Study Arms (2)

Female Partners

EXPERIMENTAL

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

Drug: Solifenacin

Male Partners

NO INTERVENTION

This arm comprises healthy male partners

Interventions

Solifenacin DRUG

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

Also known as: Vesicare

Female Partners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Loyola University: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (19)

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MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

There are no limitations or caveats to report

Results Point of Contact

• Title: Elizabeth Mueller, MD
• Organization: Loyola University Medical Center

emuelle@lumc.edu

708-216-2180

Study Officials

• Elizabeth Meuller, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 21, 2012
• Study Start: March 9, 2012
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)