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

NCT ID: NCT01611285

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-08-31

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

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Robotic Sacrocolpopexy patients

Patients who underwent Robotic Sacrocolpopexy to treat pelvic organ prolapse between 2009 and 2010

No interventions assigned to this group

UPHOLD patients

Patients who underwent the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Other vaginal procedure to correct prolapse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Culligan, MD FACOG FACS

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

Atlantic Health System Department of Urogynecology

Morristown, New Jersey, United States

Countries

United States

Other Identifiers

R10-04-002

Identifier Type: -

Identifier Source: org_study_id