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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01611285
First received: May 30, 2012
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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
Pelvic Organ Prolapse

Study Type: Observational
Official Title: Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • Surgical cure versus failure of prolapse repair [ Time Frame: within 12 months of patients surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 12 months of patients surgery ] [ Designated as safety issue: No ]
    Financial costs that will incur to produce the primary outcomes- success or failure. When the two outcomes are considered together, we have "cost effectiveness"


Enrollment: 20
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other vaginal procedure to correct prolapse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611285

Locations
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
Investigators
Principal Investigator: Patrick Culligan, MD FACOG FACS Atlantic Health System
  More Information

No publications provided

Responsible Party: Jodie Komar, Patrick Culligan, MD FACOG FACS, Director of Urogynecology and Reconstructive Pelvic Surgery within the Atlantic Health System, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01611285     History of Changes
Other Study ID Numbers: R10-04-002
Study First Received: May 30, 2012
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014