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

Far Eastern Memorial Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03764891
Enrollment
152
Registered
2018-12-05
Start date
2018-11-02
Completion date
2020-07-30
Last updated
2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Surgical Mesh

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.

Interventions

PROCEDUREUphold

Uphold system in treating women with cystocele

PROCEDUREPerigee

Perigee system in treating women with cystocele

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate of pelvic organ prolapse10 yearCompare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.

Secondary

MeasureTime frameDescription
Complication rate10 yearsCompare the complication rate (such as mesh extrusion, dyspareunia, pelvic pain, voiding difficult, etc) of Uphold system and Perigee system in treating women with cystocele.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026