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

F

Far Eastern Memorial Hospital

Status

Completed

Conditions

Pelvic Organ Prolapse
Surgical Mesh

Treatments

Procedure: Perigee
Procedure: Uphold

Study type

Observational

Funder types

Other

Identifiers

NCT03764891
107159-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

152 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

152 participants in 2 patient groups

Uphold
Description:
Patients who underwent Uphold procedure
Treatment:
Procedure: Uphold
Perigee
Description:
Patients who underwent Perigee procedure
Treatment:
Procedure: Perigee

Trial contacts and locations

1

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Central trial contact

Sheng-Mou Hsiao

Data sourced from clinicaltrials.gov

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