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Clinical Trials in Czechia / NCT03053479
Active, not recruiting Not applicable

Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh

NCT03053479 · tracked via the Priya Life Science Czechia tracker
Sponsor
Charles University, Czech Republic
Phase
Not applicable
Started
2016-09-01
Last updated
2023-02-15

Condition(s) studied

Pelvic Organ Prolapse

Investigational drug(s) / intervention(s)

Laparoscopic sacrocolpopexyTransvaginal mesh procedureAmreich-Richter procedure

Laparoscopic sacrocolpopexy: see arm/group descriptions

Transvaginal mesh procedure: see arm/group descriptions

Amreich-Richter procedure: see arm/group descriptions

Study summary

Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy of these three procedures in a randomized controlled trial.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * age over18 * signed informed consent * symptomatic pelvic organ prolapse stage III or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartments, one at least stage II and the second at least stage III * presence of at least a unilateral avulsion injury of the puborectalis muscle * agreement with postoperative follow-up. Exclusion Criteria: * previous pelvic reconstructive surgery with mesh * isolated posterior compartment prolapse * previous radiotherapy in true pelvis * contraindication for one of the planned surgical methods.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Frýdek-Místek regional hospital Frýdek-Místek Czechia
Faculty of Medicine in Olomouc, Palackeho University Olomouc Czechia
Faculty of Medicine in Pilsen, Charles University Pilsen Czechia
General University Hospital, 1st Faculty of Medicine, Charles University Prague Czechia
Hospital Na Bulovce, 1st Faculty of Medicine, Charles University Prague Czechia
Tomas Bata Regional Hospital in Zlin Zlín Czechia
Louis Pasteur University Hospital Kosice Košice Slovakia

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Other trials for the same condition

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03053479 on ClinicalTrials.gov ↗ ← All trials in Czechia