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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| Hartford Hospital | OTHER |
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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.
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| 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. |
| 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 |
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Inclusion Criteria:
Women will be eligible if they have:
Exclusion Criteria:
Women will be excluded if they have
We are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the risk of infection when placing a midurethral sling.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36897162 | Derived | Robison K, Wohlrab K, Howe CJ, Richter HE, Sung V, Bevis KS, Luis C, McCourt C, Lowder J, Occhino J, Glaser G, Lokich E, Dunivan G, Brown A, Tunitsky-Bitton E, Wethington S, Chen CCG, Rahn D, Carlson M, Cram R, Raker C, Clark MA. Endometrial Cancer Surgery With or Without Concomitant Stress Urinary Incontinence Surgery. Obstet Gynecol. 2023 Apr 1;141(4):642-652. doi: 10.1097/AOG.0000000000005059. Epub 2023 Mar 9. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Pre-op to 12 month post-op |
We will also measure post-operative pain, using the modified Brief Pain Inventory (BPI) scale.
| Day 1 in hospital after surgery |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |