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Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems

NCT ID: NCT03764891

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-02

Study Completion Date

2020-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse Surgical Mesh

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Uphold

Patients who underwent Uphold procedure

Uphold

Intervention Type PROCEDURE

Uphold system in treating women with cystocele

Perigee

Patients who underwent Perigee procedure

Perigee

Intervention Type PROCEDURE

Perigee system in treating women with cystocele

Interventions

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Uphold

Uphold system in treating women with cystocele

Intervention Type PROCEDURE

Perigee

Perigee system in treating women with cystocele

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* nil
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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107159-E

Identifier Type: -

Identifier Source: org_study_id

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