Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Charles University, Czech Republic
592 participants
Dec 1, 2022
INTERVENTIONAL
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
Inclusion Criteria4
- (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)
- Age ≥ 50 years
- Symptom bulge
- Ability to speak Czech or English
Exclusion Criteria1
- Malignancy
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Interventions
Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
The traditional transvaginal surgery for cystocele treatment used as a comparator in the study
Locations(8)
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NCT05602246