Clinical Trials Logo
  1. Home
  2. Pelvic Organ Prolapse
  3. NCT03764891
  4. Details
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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
Active, not recruiting NCT05422209 - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. N/A
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT06126328 - Materna Prep Study Phase II Phase 2
Recruiting NCT05542836 - EVeRLAST 2-Year Follow-Up
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A