Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorCharles University, Czech Republic

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 volunteers

Qualifiers

(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

Design model

Parallel

Treatments tested in this trial

  • Transobturator cystocele repair

    Procedure/Surgery

    Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.

  • Anterior colporrhaphy

    Procedure/Surgery

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

Treatment groups

592 Participants
are divided into 2 treatment groups
Group A: Transobturator cystocele repair (TOCR)Experimental treatment 1 intervention
Group B: standard anterior colporrhaphy (anterior repair - AR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Anatomic failure

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

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year
2

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

Time frame
2 years
3

2-year anatomic failure

Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. POPQ point Ba, or C of \> -1)

Time frame
2 years
4

Complication rate

Number of complications Dindo-Clavien Grade \> 2

Time frame
1 year

Other outcomes

Sponsors and contacts

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