Cancer of the Uterus and Treatment of Stress Urinary Incontinence (CUTI)
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|ClinicalTrials.gov Identifier: NCT02667431|
Recruitment Status : Unknown
Verified October 2018 by Katina Robison, Women and Infants Hospital of Rhode Island.
Recruitment status was: Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : October 2, 2018
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|Condition or disease|
|Endometrial Cancer Stress Urinary Incontinence|
|Study Type :||Observational|
|Estimated Enrollment :||556 participants|
|Official Title:||Cancer of the Uterus and Treatment of Stress Urinary Incontinence|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
- Quality of Life [ Time Frame: 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.
- Sexual Function will be measured using the female sexual function index (FSFI) [ Time Frame: 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- Time to Surgery [ Time Frame: 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.
- Clinical Outcomes- Surgical Outcomes [ Time Frame: 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 [ Time Frame: 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.
- Sling Complications [ Time Frame: 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.
- Post- Operative Pain [ Time Frame: Day 1 in hospital after surgery ]We will also measure post-operative pain, using the modified Brief Pain Inventory (BPI) scale.
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|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Women will be eligible if they have:
- clinical stage 1 or 2 (disease confined to the uterus) endometrial carcinoma or complex atypical hyperplasia
- 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
Women will be excluded if they have
- clinical stage 3 and 4 endometrial cancer
- prior pelvic radiation therapy
- vesicovaginal fistula
- urethrovaginal fistula.
- We are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the risk of infection when placing a midurethral sling.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667431
|United States, Rhode Island|
|Women & Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|Responsible Party:||Katina Robison, MD, Women and Infants Hospital of Rhode Island|
|Other Study ID Numbers:||
|First Posted:||January 29, 2016 Key Record Dates|
|Last Update Posted:||October 2, 2018|
|Last Verified:||October 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Genital Neoplasms, Female
Neoplasms by Site