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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Loyola University
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Elizabeth Mueller, Loyola University
ClinicalTrials.gov Identifier:
NCT01559389
First received: March 15, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Study the quality of the relationship in couples affected by Urge Urinary Incontinence (UUI) and identify how treatment may improve the relationship.


Condition Intervention
Urge Urinary Incontinence
Drug: solifenacin succinate

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Levels of relationship satisfaction and sexual function among couples with the female partner having primarily: UUI symptoms and mixed urinary incontinence (urge predominant). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

    Women will complete questionnaires:

    • The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire and the Pelvic Floor Impact Questionnaire-Short Form 7, validated questionnaires measuring the impact of pelvic floor dysfunction, including urinary incontinence, on sexual function and general quality of life, respectively.
    • The Golombok-Rust Inventory of Sexual Satisfaction
    • The Dyadic Adjustment Scale

    Men will complete questionnaires:

    • The Golombok-Rust Inventory of Sexual Satisfaction
    • The Dyadic Adjustment Scale


Secondary Outcome Measures:
  • The impact of successful treatment of UUI on the relationship. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Women will complete questionnaires:

    • The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire and the Pelvic Floor Impact Questionnaire-Short Form 7, validated questionnaires measuring the impact of pelvic floor dysfunction, including urinary incontinence, on sexual function and general quality of life, respectively.
    • The Golombok-Rust Inventory of Sexual Satisfaction
    • The Dyadic Adjustment Scale

    Men will complete questionnaires:

    • The Golombok-Rust Inventory of Sexual Satisfaction
    • The Dyadic Adjustment Scale


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
solifenacin succinate
Open Label
Drug: solifenacin succinate
5 mg daily up to 10 mg daily
Other Name: Vesicare

Detailed Description:

The importance of this study 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women will eligible for inclusion in the study if they are:
  • Age ≥ 18 years, and
  • In a relationship with a male partner for at least 3 months, and
  • Not pregnant (pregnancy test will be done at study enrollment) or planning to become pregnant, and
  • Have a diagnosis of UUI or MUI, urge predominant, based upon a 3 day voiding diary, and
  • Are interested in medical management of their symptoms and are candidates for Vesicare, and
  • Able to provide informed consent and complete the written questionnaires.

Exclusion Criteria:

  • PVR > 200 ml at initial visit
  • Significant outflow obstruction
  • Persistent/recurrent UTI
  • Bladder stones
  • A diagnosis of chronic interstitial cystitis
  • Undergone 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 (MS)
  • A diagnosis of chronic pelvic pain
  • An active psychotic disorder
  • Or their partner is non-English speaking
  • Decline permission for the study team to approach their partner regarding participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559389

Contacts
Contact: Mary Tulke, RN 708-216-2067 mtulke@luc.edu

Locations
United States, Illinois
Loyola Univ Med Cntr - Dept of urology & obstetrics / Gynecology Recruiting
Maywood, Illinois, United States, 60153
Contact: Mary Tulke, RN    708-216-2067    mtulke@luc.edu   
Principal Investigator: Elizabeth Meuller, MD         
Sub-Investigator: Linda Brubaker, MD         
Sub-Investigator: Cynthia Brincat, MD         
Sponsors and Collaborators
Loyola University
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Elizabeth Meuller, MD Loyola Univ Med Cntr - Dept of Urology & Obstetrics/Gynecology
  More Information

No publications provided

Responsible Party: Elizabeth Mueller, M.D., Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01559389     History of Changes
Other Study ID Numbers: 203952
Study First Received: March 15, 2012
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Loyola University:
Urge Urinary Incontinence
Vesicare
Urinary Incontinence
Sexual function

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014