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

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03764891
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Surgical Mesh	Procedure: Uphold; Procedure: Perigee

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 Design

• Study Type: Observational
• Anticipated Enrollment: 210 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Far Eastern Memorial Hospital
• Actual Study Start Date: Nov 2, 2018
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Uphold Patients who underwent Uphold procedure	Procedure: Uphold; Uphold system in treating women with cystocele
Perigee Patients who underwent Perigee procedure	Procedure: Perigee; Perigee system in treating women with cystocele

Outcome Measures

Primary Outcome Measures

1. Recurrence rate of pelvic organ prolapse [10 year]

   Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.

Secondary Outcome Measures

1. Complication rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03764891
• Other Study ID Numbers: 107159-E
• First Posted: Dec 5, 2018
• Last Update Posted: Dec 9, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Dec 9, 2020