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

Completed

• Conditions: Surgical Mesh; Pelvic Organ Prolapse
• Interventions: Procedure: Uphold; Procedure: Perigee

• Registration Number: NCT03764891
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Study Start: 2018-11-02
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Primary Completion: 2020-04-28
• Study Completion: 2020-07-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uphold	Uphold	Patients who underwent Uphold procedure
Perigee	Perigee	Patients who underwent Perigee procedure

Primary Outcome Measures

Name	Time	Method
Recurrence rate of pelvic organ prolapse	10 year	Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.

Secondary Outcome Measures

Name	Time	Method
Complication rate	10 years	Compare the complication rate (such as mesh extrusion, dyspareunia, pelvic pain, voiding difficult, etc) of Uphold system and Perigee system in treating women with cystocele.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan