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Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment

NCT05420831 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-12-27

No results posted yet for this study

Summary

This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the impact of the surgery on quality of life.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Vaginal

Sacrospinous hysteropexy using the synthetic mesh

PROCEDURE

Laparoscopic

Laparoscopic Sacrohysteropexy

Sponsors & Collaborators

  • Saint Petersburg State University, Russia

    lead OTHER

Principal Investigators

  • Dmitry Shkarupa, MD, PhD · Saint Petersburg State University, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2023-08-02
Completion
2025-05-09

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05420831 on ClinicalTrials.gov