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OpenTrials
Completed

NCT Number: NCT03764891

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

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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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Surgical Mesh

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • nil

Treatment and study plan

Uphold

Procedure

Uphold system in treating women with cystocele

Perigee

Procedure

Perigee system in treating women with cystocele

Primary outcomes

  1. 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

  1. Complication rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Far Eastern Memorial Hospital

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2018
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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