NCT01611285

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

May 30, 2012

Last Update Submit

June 8, 2017

Conditions

Pelvic Organ Prolapse

Keywords

UPHOLDrobotic surgerydecision analysisFDAdecision nodeoutcome node

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Financial costs of outcomes

    within 12 months of patients surgery

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 patients who underwent either robotic surgery or the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010

You may qualify if:

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

You may not qualify if:

  • Other vaginal procedure to correct prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System Department of Urogynecology

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Culligan, MD FACOG FACS

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 4, 2012

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

US(1)