The average lifetime risk of breast cancer for a woman in the United States has been estimated at 12.3% (ie, 1 in 8 women). 1 For 2018, the American Cancer Society (ACS) estimates that 63,960 cases of female carcinoma in situ of the breast and 268,670 cases of invasive breast cancer (266,120 women and 2,550 men) will be diagnosed in the United States. 2 About 41,400 deaths are estimated for 2018. 3 The good news is that death rates have been falling on average NCCN
Women in the United States have a 12.3% estimated lifetime risk for developing breast cancer (i.e., 1 in 8 women). 1 In 2009, an estimated 194,290 cases of invasive breast cancer (192,370 women and 1919 men) and 62,280 cases of female carcinoma in situ of the breast will be diagnosed in the United States, with 40,610 deaths from invasive breast cancer predicted. 2 However, mortality from breast cancer has decreased slightly, attributed partly to mammographic screening. 3 The NCCN Breast Cancer Screening and Diagnosis Panel designed these practice guidelines to fa-The NCCN
Background
Many women without preexisting stress urinary incontinence (SUI) who undergo vaginal surgery to correct pelvic organ prolapse will develop symptoms of SUI. A concomitant prophylactic anti-incontinence procedure may prevent SUI symptom development in women undergoing vaginal prolapse surgery.
Purpose
To present the rationale, design and methodology of a randomized controlled surgical trial (RCT), the Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial. The primary aims of this RCT are to determine (1) whether the prevalence of post-operative urinary incontinence (UI) differs between stress continent women receiving vaginal prolapse repair with concomitant tension-free vaginal tape (TVT®; a sling procedure commonly used to treat SUI) and those with only sham incisions at 3 months post surgery (2) whether it is more cost-effective to place a TVT prophylactically than to treat the SUI symptoms postoperatively as they occur over a 12 month period after the index surgery.. The study also incorporates a patient preference trial (PPT).
Methods
Primary outcome, defined as signs (positive cough stress test), symptoms (per validated questionnaire) and/or need for treatment of SUI and its associated cost, at 3 and 12 months post-operatively. Secondary outcomes consist of group differences in lower urinary tract and prolapse symptoms, health related quality of life, measures of vaginal anatomy, and surgical complications.
Limitations
Given the invasive nature of surgical intervention trials, some individuals may be reluctant to agree with random assignment, potentially impacting result generalizability. To evaluate the magnitude and direction of non-participation bias, the PPT will enroll a sample of those who decline participation in the RCT but are otherwise eligible.
Conclusion
This sham-controlled RCT will provide important information for patients and surgeons regarding both the short- and long-term optimal treatment approach for stress continent women undergoing a vaginal surgery for prolapse. Non-participation bias will be estimated.
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