Cancer of the Uterus and Treatment of Stress Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

556 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometrial Cancer Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No