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Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

NCT05602246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2026-03-19

No results posted yet for this study

Summary

Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology. Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles. Clinically, these defects are often combined and/or may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. After the ban on transvaginal meshes, the interest in native tissue repair has risen. Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction. There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery. A novel method of transvaginal paravaginal defect repair - TOCR (transobturator cystocele repair) was suggested. The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair.

Conditions

  • Pelvic Organ Prolapse
  • Cystocele
  • Cystocele and Incomplete Uterovaginal Prolapse

Interventions

PROCEDURE

Transobturator cystocele repair

Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.

PROCEDURE

Anterior colporrhaphy

The traditional transvaginal surgery for cystocele treatment used as a comparator in the study

Sponsors & Collaborators

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Vladimir Kalis, prof. MD PhD · Faculty of Medicine in Plzen, Charles University

  • Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG · Faculty of Medicine in Plzen, Charles University

  • Zdenek Rusavy, assoc. prof. MD PhD · Faculty of Medicine in Plzen, Charles University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2029-11-01
Completion
2034-11-01

Countries

  • Czechia
  • Slovakia

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 NCT05602246 on ClinicalTrials.gov