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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01611285
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : June 9, 2017
Boston Scientific Corporation
Information provided by (Responsible Party):
Atlantic Health System

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
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
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 : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Surgical cure versus failure of prolapse repair [ Time Frame: 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 :
  1. Financial costs of outcomes [ Time Frame: 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"

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

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

Exclusion Criteria:

  • Other vaginal procedure to correct prolapse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01611285

United States, New Jersey
Atlantic Health System Department of Urogynecology
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Boston Scientific Corporation
Principal Investigator: Patrick Culligan, MD FACOG FACS Atlantic Health System

Responsible Party: Atlantic Health System Identifier: NCT01611285     History of Changes
Other Study ID Numbers: R10-04-002
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Atlantic Health System:
robotic surgery
decision analysis
decision node
outcome node

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical