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Completed

NCT Number: NCT01611285

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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Atlantic Health System Department of Urogynecology

Morristown, New Jersey, 07960, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other vaginal procedure to correct prolapse

Treatment and study plan

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 4, 2012
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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