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Clinical Trials/NCT03764891
NCT03764891
Completed
Not Applicable

Far Eastern Memorial Hospital

Far Eastern Memorial Hospital1 site in 1 country152 target enrollmentNovember 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Far Eastern Memorial Hospital
Enrollment
152
Locations
1
Primary Endpoint
Recurrence rate of pelvic organ prolapse
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Registry
clinicaltrials.gov
Start Date
November 2, 2018
End Date
July 30, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Far Eastern Memorial Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recurrence rate of pelvic organ prolapse

Time Frame: 10 year

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

Secondary Outcomes

  • Complication rate(10 years)

Study Sites (1)

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