Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS (STARS)
Pelvic Organ Prolapse, Cystocele, Cystocele and Incomplete Uterovaginal Prolapse
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Quality of life, TOCR, Anterior vaginal wall repair, Transobturator cystocele repair
Eligibility Criteria
Inclusion Criteria: (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1) Age ≥ 50 years Symptom bulge Ability to speak Czech or English Exclusion Criteria: Malignancy
Sites / Locations
- Faculty of Medicine in Hradec Kralove, Charles University
- Medical Faculty, Ostrava University
- Hospital Pardubice Region, Inc.
- Faculty of Medicine in Pilsen, Charles UniversityRecruiting
- Hospital na Bulovce, 1st Medical Faculty, Charles University
- Tomas Bata Regional Hospital in Zlin
- Košice Medical University
- Trenčianska univerzita Alexandra Dubčeka
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Transobturator cystocele repair (TOCR)
standard anterior colporrhaphy (anterior repair - AR)
The technique of TOCR was published previously including a video [Kalis et al. Trans-obturator cystocele repair (TOCR) of level 2 paravaginal defect. Int Urogynecol J. 2020, 31(11):2435-38. doi:10.1007/s00192-020-04337-x]. The anterior vaginal wall is incised in the midline and the pubocervical fascia is dissected to open the paravaginal space towards the ATFP and the fascia of the obturator internus muscle. 3-4 continuous non-locking stitches of non-absorbable suture 1-0 Ti-Cron™ braided polyester are taken into the pubocervical fascia and threaded using Shirodkar needles through skin incisions in genitofemoral sulci passing through the full thickness of the obturator membrane, obturator internus muscle. After closure of the vaginal skin incision, both ends of the Ti-Cron™ sutures are tied ensuring the obliteration of the paravaginal defect. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.
The anterior vaginal wall is incised in the midline from the level of the bladder neck up to vaginal apex or anterior vaginal fornix. The bladder is sharply dissected from the vaginal wall with pubocervical fascia attached to the bladder wall. The fascia is approximated in the midline with several simple interrupted 0 polyglactin 910 sutures or equivalent. The surplus of distended vaginal epithelium is trimmed. The vaginal incision is closed using a continuous non-locking polyglactin 910 2-0 suture or equivalent. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.