Cancer of the Uterus and Treatment of Stress Urinary Incontinence (CUTI)

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 Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence; Endometrial Cancer

• Study Type: Observational
• Enrollment (Anticipated): 556

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed complex atypical hyperplasia or clinical stage 1 or 2 endometrial cancer based on physical exam and/or imaging will be approached.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The purpose of this study is to compare quality of life among women with endometrial cancer and SUI who undergo SUI and endometrial cancer surgery simultaneously to women that do not.	Pre-op to 12 month post-op
Sexual Function will be measured using the female sexual function index (FSFI)	Compare the sexual function of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only. Sexual function will be measured using the female sexual function index (FSFI). It is a 19-item instrument assessing 6 domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain.	Pre-op to 12 month post-op
Clinical Outcomes- Time to Surgery	Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only, by measuring time to surgery (ie: number of days) using hospital records. The estimated time to surgery will be assessed up to 12 weeks, measuring from initial date of enrollment to date of documented surgery date.	Enrollment to Day of Surgery
Clinical Outcomes- Surgical Outcomes	Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only by examining surgical outcomes such as intra op injuries or complications using hospital records.	Pre-op to 12 month post-op
Clinical Outcomes- Post-Operative Complications	Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only by examining Post-Operative complications. We will document any treatment-related adverse events as assessed by CTCAE v4.0. We will use hospital records.	Pre-op to 12 month post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sling Complications	Compare the rate of midurethral sling complications among women who received radiation after sling placement to women who did not receive radiation using hospital records.	Pre-op to 12 month post-op
Post- Operative Pain	We will also measure post-operative pain, using the modified Brief Pain Inventory (BPI) scale.	Day 1 in hospital after surgery

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: University of Alabama at Birmingham; Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: SUI
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Genital Neoplasms, Female; Uterine Diseases; Urination Disorders; Elimination Disorders; Urinary Incontinence; Endometrial Neoplasms; Enuresis; Urinary Incontinence, Stress; Uterine Neoplasms
• Other Study ID Numbers: 823303-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO