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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611285
• Other study ID #: R10-04-002
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: June 8, 2017
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Female

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

Exclusion Criteria:

• Other vaginal procedure to correct prolapse

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	Atlantic Health System Department of Urogynecology	Morristown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic Health System	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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