Clinical trial NCT02667431: Cancer of the Uterus and Treatment of Stress Urinary Incontinence
Official title: Cancer of the Uterus and Treatment of Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Stress Urinary Incontinence
Keywords: SUI
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Hartford Hospital
First posted: 2016-01-29
Enrollment: 556
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life
timeFrame: Pre-op to 12 month post-op
measure: Sexual Function will be measured using the female sexual function index (FSFI)
timeFrame: Pre-op to 12 month post-op
measure: Clinical Outcomes- Time to Surgery
timeFrame: Enrollment to Day of Surgery
measure: Clinical Outcomes- Surgical Outcomes
timeFrame: Pre-op to 12 month post-op
measure: Clinical Outcomes- Post-Operative Complications
timeFrame: Pre-op to 12 month post-op
Secondary outcomes:
measure: Sling Complications
timeFrame: Pre-op to 12 month post-op
measure: Post- Operative Pain
timeFrame: Day 1 in hospital after surgery
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
References: