Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

NCT05602246 | Recruiting DMC

• 1 other identifier: STARS
• Study Type: interventional
• Target: 592
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Pelvic Organ Prolapse; Cystocele; Cystocele and Incomplete Uterovaginal Prolapse

Keywords

Pelvic organ prolapse; Quality of life; TOCR; Anterior vaginal wall repair; Transobturator cystocele repair

Outcome Measures

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)

  1 year

Secondary Outcomes (15)

• Composite surgery failure

  1 year

• 2-year composite surgery failure

  2 years

• 2-year anatomic failure

  2 years

• Complication rate

  1 year

• Pain after the surgery

  Postoperative day 14

Study Arms (2)

Transobturator cystocele repair (TOCR)

EXPERIMENTAL

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.

Procedure: Transobturator cystocele repair

standard anterior colporrhaphy (anterior repair - AR)

ACTIVE COMPARATOR

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.

Procedure: Anterior colporrhaphy

Interventions

Transobturator cystocele repair PROCEDURE

Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.

Also known as: TOCR

Transobturator cystocele repair (TOCR)

Anterior colporrhaphy PROCEDURE

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

Also known as: Anterior repair

standard anterior colporrhaphy (anterior repair - AR)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)
• Age ≥ 50 years
• Symptom bulge
• Ability to speak Czech or English

You may not qualify if:

• Malignancy

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (8)

Faculty of Medicine in Hradec Kralove, Charles University

Hradec Králové, 500 05, Czechia

NOT YET RECRUITING

Medical Faculty, Ostrava University

Ostrava-Poruba, 708 52, Czechia

NOT YET RECRUITING

Hospital Pardubice Region, Inc.

Pardubice, 530 03, Czechia

NOT YET RECRUITING

Faculty of Medicine in Pilsen, Charles University

Pilsen, 30000, Czechia

RECRUITING

Hospital na Bulovce, 1st Medical Faculty, Charles University

Prague, 18000, Czechia

NOT YET RECRUITING

Tomas Bata Regional Hospital in Zlin

Zlín, 762 75, Czechia

NOT YET RECRUITING

Košice Medical University

Košice, 040 11, Slovakia

NOT YET RECRUITING

Trenčianska univerzita Alexandra Dubčeka

Trenčín, 911 01, Slovakia

NOT YET RECRUITING

Related Publications (13)

• Lowenstein E, Ottesen B, Gimbel H. Incidence and lifetime risk of pelvic organ prolapse surgery in Denmark from 1977 to 2009. Int Urogynecol J. 2015 Jan;26(1):49-55. doi: 10.1007/s00192-014-2413-y. Epub 2014 May 20.

  PMID: 24842118 BACKGROUND

• Otcenasek M, Gauruder-Burmester A, Haak LA, Grill R, Popken G, Baca V. Paravaginal defect: A new classification of fascial and muscle tears in the paravaginal region. Clin Anat. 2016 May;29(4):524-9. doi: 10.1002/ca.22694. Epub 2016 Feb 14.

  PMID: 26800142 BACKGROUND

• Arenholt LTS, Pedersen BG, Glavind K, Glavind-Kristensen M, DeLancey JOL. Paravaginal defect: anatomy, clinical findings, and imaging. Int Urogynecol J. 2017 May;28(5):661-673. doi: 10.1007/s00192-016-3096-3. Epub 2016 Sep 17.

  PMID: 27640064 BACKGROUND

• Arenholt LTS, Pedersen BG, Glavind K, Greisen S, Bek KM, Glavind-Kristensen M. Prospective evaluation of paravaginal defect repair with and without apical suspension: a 6-month postoperative follow-up with MRI, clinical examination, and questionnaires. Int Urogynecol J. 2019 Oct;30(10):1725-1733. doi: 10.1007/s00192-018-3807-z. Epub 2018 Dec 1.

  PMID: 30506182 BACKGROUND

• de Tayrac R, Boileau L, Fara JF, Monneins F, Raini C, Costa P. Bilateral anterior sacrospinous ligament suspension associated with a paravaginal repair with mesh: short-term clinical results of a pilot study. Int Urogynecol J. 2010 Mar;21(3):293-8. doi: 10.1007/s00192-009-1036-1.

  PMID: 19924370 BACKGROUND

• Ward RM, Sung VW, Clemons JL, Myers DL. Vaginal paravaginal repair with an AlloDerm graft: Long-term outcomes. Am J Obstet Gynecol. 2007 Dec;197(6):670.e1-5. doi: 10.1016/j.ajog.2007.08.067.

  PMID: 18060976 BACKGROUND

• Chinthakanan O, Miklos JR, Moore RD. Laparoscopic Paravaginal Defect Repair: Surgical Technique and a Literature Review. Surg Technol Int. 2015 Nov;27:173-83.

  PMID: 26680393 BACKGROUND

• Delancey JO. Fascial and muscular abnormalities in women with urethral hypermobility and anterior vaginal wall prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):93-8. doi: 10.1067/mob.2002.125733.

  PMID: 12114894 BACKGROUND

• Holt E. US FDA rules manufacturers to stop selling mesh devices. Lancet. 2019 Apr 27;393(10182):1686. doi: 10.1016/S0140-6736(19)30938-9. No abstract available.

  PMID: 31034366 BACKGROUND

• Leffler KS, Thompson JR, Cundiff GW, Buller JL, Burrows LJ, Schon Ybarra MA. Attachment of the rectovaginal septum to the pelvic sidewall. Am J Obstet Gynecol. 2001 Jul;185(1):41-3. doi: 10.1067/mob.2001.116366.

  PMID: 11483901 BACKGROUND

• Kalis V, Kovarova V, Rusavy Z, Ismail KM. Trans-obturator cystocele repair of level 2 paravaginal defect. Int Urogynecol J. 2020 Nov;31(11):2435-2438. doi: 10.1007/s00192-020-04337-x. Epub 2020 Jun 3.

  PMID: 32494957 BACKGROUND

• Jelovsek JE, Gantz MG, Lukacz E, Sridhar A, Zyczynski H, Harvie HS, Dunivan G, Schaffer J, Sung V, Varner RE, Mazloomdoost D, Barber MD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2021 Apr;224(4):362.e1-362.e11. doi: 10.1016/j.ajog.2020.10.009. Epub 2020 Oct 8.

  PMID: 33039390 BACKGROUND

• Delacroix C, Allegre L, Chatziioannidou K, Gerard A, Fatton B, de Tayrac R. Anterior bilateral sacrospinous ligament fixation with concomitant anterior native tissue repair: a pilot study. Int Urogynecol J. 2022 Dec;33(12):3519-3527. doi: 10.1007/s00192-022-05092-x. Epub 2022 Feb 28.

  PMID: 35226145 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse; Cystocele

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vladimir Kalis, prof. MD PhD

  Faculty of Medicine in Plzen, Charles University

  STUDY CHAIR

• Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG

  Faculty of Medicine in Plzen, Charles University

  STUDY DIRECTOR

• Zdenek Rusavy, assoc. prof. MD PhD

  Faculty of Medicine in Plzen, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Kalis, prof. MD PhD

CONTACT

+420377105228; kalisv@fnplzen.cz

Zdenek Rusavy, assoc. prof. MD PhD

CONTACT

+420377105440; rusavyz@fnplzen.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. MD PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 2, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2034
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CZ (6); SL (2)