- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764891
Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems
September 14, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
152
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sheng-Mou Hsiao
- Phone Number: +886919302632
- Email: smhsiao2@gmail.com
Study Locations
-
-
New Taipei
-
Banqiao, New Taipei, Taiwan, 22050
- Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pelvic organ prolapse patients underwent Uphold or Perigee surgeries
Description
Inclusion Criteria:
- Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
- Underwent Uphold or Perigee procedures
Exclusion Criteria:
- nil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Uphold
Patients who underwent Uphold procedure
|
Uphold system in treating women with cystocele
|
Perigee
Patients who underwent Perigee procedure
|
Perigee system in treating women with cystocele
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2018
Primary Completion (Actual)
April 28, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
December 4, 2018
First Submitted That Met QC Criteria
December 4, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107159-E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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