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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01611285

Enrollment

Registered

2012-06-04

Start date

2010-11-30

Completion date

2011-08-31

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

UPHOLD, robotic surgery, decision analysis, FDA, decision node, outcome node

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Female * Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse

Exclusion criteria

* Other vaginal procedure to correct prolapse

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results