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Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study

NCT04478747 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2025-09-24

No results posted yet for this study

Summary

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane.

The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

Conditions

  • Prolapse, Vaginal Vault

Interventions

PROCEDURE

TVM

Transvaginal mesh operation using BSC mesh (A.M.I., Feldkirch, Austria)

PROCEDURE

Colposacropexy

Colposacropexy using EndoGYNious mesh (A.M.I., Feldkirch, Austria)

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2031-12-31
Completion
2032-12-31

Countries

  • Finland

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 NCT04478747 on ClinicalTrials.gov