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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Department of Urogynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

20 patients who underwent either robotic surgery or the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Other vaginal procedure to correct prolapse

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Patrick Culligan, MD FACOG FACS, Atlantic Health System

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: robotic surgery; FDA; UPHOLD; decision analysis; decision node; outcome node
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: R10-04-002