NCT03764891

Brief Summary

Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

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 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

December 4, 2018

Last Update Submit

September 14, 2023

Conditions

Pelvic Organ ProlapseSurgical Mesh

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of pelvic organ prolapse

    Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.

    10 year

Secondary Outcomes (1)

  • Complication rate

    10 years

Study Arms (2)

Uphold

Patients who underwent Uphold procedure

Procedure: Uphold

Perigee

Patients who underwent Perigee procedure

Procedure: Perigee

Interventions

UpholdPROCEDURE

Uphold system in treating women with cystocele

Uphold
PerigeePROCEDURE

Perigee system in treating women with cystocele

Perigee

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pelvic organ prolapse patients underwent Uphold or Perigee surgeries

You may qualify if:

  • Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
  • Underwent Uphold or Perigee procedures

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 5, 2018

Study Start

November 2, 2018

Primary Completion

April 28, 2020

Study Completion

July 30, 2020

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

TW(1)