Endometrial Cancer, Stress Urinary Incontinence
Conditions
Keywords
SUI
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.
Interventions
None listed
Sponsors
University of Alabama at Birmingham
Hartford Hospital
Women and Infants Hospital of Rhode Island
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function will be measured using the female sexual function index (FSFI) | Pre-op to 12 month post-op | 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. |
| Clinical Outcomes- Surgical Outcomes | Pre-op to 12 month post-op | 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. |
| Clinical Outcomes- Post-Operative Complications | Pre-op to 12 month post-op | 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. |
| Quality of Life | Pre-op to 12 month post-op | 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. |
| Clinical Outcomes- Time to Surgery | Enrollment to Day of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post- Operative Pain | Day 1 in hospital after surgery | We will also measure post-operative pain, using the modified Brief Pain Inventory (BPI) scale. |
| Sling Complications | Pre-op to 12 month post-op | 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. |
Countries
United States
Outcome results
None listed