About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
(at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)
Age ≥ 50 years
Symptom bulge
Ability to speak Czech or English
Disqualifiers
Malignancy
Trial design
Parallel
Treatments tested in this trial
Transobturator cystocele repair
Procedure/SurgeryNovel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
Anterior colporrhaphy
Procedure/SurgeryThe traditional transvaginal surgery for cystocele treatment used as a comparator in the study
Treatment groups
Trial outcomes
Primary outcomes
Anatomic failure
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of \> -1)
Secondary outcomes
Composite surgery failure
Composite measure requiring at least one from the following: 1. anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of \> 0), 2. subjective failure (presence of bothersome vaginal bulge symptoms), or 3. pessary or surgical retreatment for pelvic organ prolapse
2-year composite surgery failure
Composite measure requiring at least one from the following: 1. anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of \> 0), 2. subjective failure (presence of bothersome vaginal bulge symptoms), or 3. pessary or surgical retreatment for pelvic organ prolapse
2-year anatomic failure
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. POPQ point Ba, or C of \> -1)
Complication rate
Number of complications Dindo-Clavien Grade \> 2
Sponsors and contacts
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