Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Condition(s) studied

Investigational drug(s) / intervention(s)

Transobturator cystocele repair: Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.

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

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.

Eligibility

Primary outcome measure(s)

• Anatomic failure — 1 year
  Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of \> -1)

Trial sites (8)

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