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

Sponsor

Atlantic Health System (Other)

Overall Status

Completed

CT.gov ID

NCT01611285

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Surgical cure versus failure of prolapse repair [within 12 months of patients surgery]
Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure

Secondary Outcome Measures

Financial costs of outcomes [within 12 months of patients surgery]
Financial costs that will incur to produce the primary outcomes- success or failure. When the two outcomes are considered together, we have "cost effectiveness"