Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach

Study Overview
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Brief Summary
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Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy

Detailed Description
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The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US. Treatment Choice of Patients: Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients. When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.

Official Title
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Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse Exclusion Criteria: Other vaginal procedure to correct prolapse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic Sacrocolpopexy patients<br>Patients who underwent Robotic Sacrocolpopexy to treat pelvic organ prolapse between 2009 and 2010 | |
| UPHOLD patients<br>Patients who underwent the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical cure versus failure of prolapse repair | Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure | within 12 months of patients surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial costs of outcomes | Financial costs that will incur to produce the primary outcomes- success or failure. When the two outcomes are considered together, we have cost effectiveness | within 12 months of patients surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UPHOLD, robotic surgery, decision analysis, FDA, decision node, outcome node