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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

March 15, 2012
June 3, 2014
March 2012
March 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01559389 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Incontinence & Intimate Partners: Assessing the Contribution of Treatment
Incontinence & Intimate Partners: Assessing the Contribution of Treatment

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Urge Urinary Incontinence
Drug: solifenacin succinate
5 mg daily up to 10 mg daily
Other Name: Vesicare
solifenacin succinate
Open Label
Intervention: Drug: solifenacin succinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 89 Years
No
Contact: Mary Tulke, RN 708-216-2067 mtulke@luc.edu
United States
 
NCT01559389
203952
No
Elizabeth Mueller, Loyola University
Loyola University
Astellas Pharma US, Inc.
Principal Investigator: Elizabeth Meuller, MD Loyola Univ Med Cntr - Dept of Urology & Obstetrics/Gynecology
Loyola University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP