Brief Title
Cancer of the Uterus and Treatment of Stress Urinary Incontinence
Official Title
Cancer of the Uterus and Treatment of Stress Urinary Incontinence
Brief Summary
Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical
health and decrease costs for both patients and the health care system. At the time of
endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a
gynecologic oncologist, but the majority will undergo surgery within weeks of their
diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and
concurrent surgery performed. This would spare the patient two surgeries, decrease the
emotional distress associated with SUI symptoms, decrease the costs associated with SUI for
the patient and possibly improve overall quality of life. The proposed study will compare the
quality of life and clinical outcomes among women with endometrial cancer and SUI that have
concurrent surgery to women that do not have concurrent surgery. The findings of our proposed
research will provide valuable information necessary for woman and clinicians to make
decisions regarding the treatment of SUI, including evidence regarding the risks and benefits
of performing concurrent endometrial cancer and SUI surgery.
Study Type
Observational
Primary Outcome
Quality of Life
Secondary Outcome
Sling Complications
Condition
Endometrial Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
556
Start Date
January 2016
Completion Date
April 2019
Primary Completion Date
April 2019
Eligibility Criteria
Inclusion Criteria:
- Women will be eligible if they have:
1. clinical stage 1 or 2 (disease confined to the uterus) endometrial carcinoma or
complex atypical hyperplasia
2. answer yes to one screening question: "Do you ever leak urine when you cough,
sneeze, jump or laugh?" We will include women with complex atypical hyperplasia
(CAH) because 40% of these women will have an endometrial cancer identified at
the time of surgery and the risk factors are the same for CAH as they are for
clinical stage 1 and 2 endometrial cancers
Exclusion Criteria:
- Women will be excluded if they have
1. clinical stage 3 and 4 endometrial cancer
2. prior pelvic radiation therapy
3. vesicovaginal fistula
4. urethrovaginal fistula.
- We are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the
risk of infection when placing a midurethral sling.
Gender
Female
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02667431
Organization ID
823303-1
Responsible Party
Principal Investigator
Study Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
University of Alabama at Birmingham
Study Sponsor
, ,
Verification Date
October 2018