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Evaluation of Efficacy and Safety of Urogynecology Synthetic Mesh Surgery in Women With Pelvic Organ Prolapse
This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.
Gynecologic mesh, including transvaginal mesh and mesh used in abdominal or laparoscopic sacrocolpopexy, has been used for pelvic organ prolapse since its debut in the US in 2005. It provides higher success and satisfaction rate than traditional colporrhaphy, but mesh-related complications, such as pain, mesh exposure and bleeding, have been reported. U.S. Food and Drug Administration issued a Safety Update in 2011 to inform the public that serious complications associated with synthetic mesh for the transvaginal repair of POP were common. Taiwan FDA and associated committees decided that the use of gynecologic mesh should be regulated. Thorough study and evaluation are needed.
Age
30 - 100 years
Sex
FEMALE
Healthy Volunteers
No
Department of Obstetrics and Gynecology
New Taipei City, Taiwan
Start Date
August 1, 2022
Primary Completion Date
August 1, 2023
Completion Date
December 31, 2027
Last Updated
April 5, 2023
150
ESTIMATED participants
Urodynamic investigations before and after a mesh surgery protocol.
PROCEDURE
Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.
PROCEDURE
Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair
PROCEDURE
Lead Sponsor
Mackay Medical College
NCT05602246
NCT05042453
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04110821