Cancer of the Uterus and Treatment of Stress Urinary Incontinence

Endometrial Cancer Clinical Trial

— CUTI  

Official title:

Cancer of the Uterus and Treatment of Stress Urinary Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02667431
• Other study ID #: 823303-1
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: April 2019

Study information

• Verified date: October 2018
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 556
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Uterine Neoplasms

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Hartford Hospital, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Post- Operative Pain	We will also measure post-operative pain, using the modified Brief Pain Inventory (BPI) scale.	Day 1 in hospital after surgery