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NCT03764891 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

Official title:
Far Eastern Memorial Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03764891
Other study ID # 107159-E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2018
Est. completion date July 30, 2020

Study information
Verified date September 2023
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 152
Est. completion date July 30, 2020
Est. primary completion date April 28, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Uphold
Uphold system in treating women with cystocele
• Perigee
Perigee system in treating women with cystocele

Locations
Country Name City State
Taiwan Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate of pelvic organ prolapse Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele. 10 year
Secondary Complication rate 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. 10 years
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