Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach
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
Pelvic Organ Prolapse
|Official Title:||Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach|
- Surgical cure versus failure of prolapse repair [ Time Frame: within 12 months of patients surgery ] [ Designated as safety issue: No ]Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure
- Financial costs of outcomes [ Time Frame: within 12 months of patients surgery ] [ Designated as safety issue: No ]Financial costs that will incur to produce the primary outcomes- success or failure. When the two outcomes are considered together, we have "cost effectiveness"
|Study Start Date:||November 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Robotic Sacrocolpopexy patients
Patients who underwent Robotic Sacrocolpopexy to treat pelvic organ prolapse between 2009 and 2010
Patients who underwent the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611285
|United States, New Jersey|
|Atlantic Health System Department of Urogynecology|
|Morristown, New Jersey, United States, 07960|
|Principal Investigator:||Patrick Culligan, MD FACOG FACS||Atlantic Health System|