Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Обзор

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.

Подробное описание

Pelvic organ prolapse (POP) has a negative impact on the quality of life of affected women and anterior compartment defects remain the most challenging to repair. It was reported that a women has almost a 1 in 5 risk of needing any kind of POP surgery in her lifetime, with anterior wall repair accounting for 40.6% of all of these. Depending on the structures affected, cystocele can be secondary to defects at: A) Level I vaginal support, provided by the uterosacral and cardinal ligaments or B) Level II vaginal support, mainly provided by the pubocervical fascia. Level II defects can be midline or lateral (paravaginal) depending on whether the fascia is weak at the midline or detached from its lateral attachment to the arcus tendineus fasciae pelvis (ATFP). 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. These involve native tissue and the use of mesh implanted transvaginally and / or transabdominally.The mainstay for the vaginal repair of a level I defects is to anchor the uterine cervix or vaginal vault to the sacrospinous or the anterior longitudinal ligaments. However, proper restoration of a level II defect is more complex. Although, a classical anterior colporrhaphy might be suitable to correct an isolated midline weakness in the endopelvic fascia, it is suboptimal, on its own, for the repair an associated lateral defect, which is a common association. Indeed, De Lancey reported that paravaginal defects (PVDs) were diagnosed in 89% of women undergoing surgery for cystocele and stress urinary incontinence.

Although a variety of techniques for paravaginal defect repair (PVDR) have been suggested, several of these are now not feasible in many countries following the FDA's ban on transvaginal mesh manufacture, sale and distribution. Therefore, currently there are attempts to utilize minimally invasive approaches and modern devices in PVDR native tissue repair. Applying this principle, e.g. Capio Suture Capturing Device (Boston Scientific) has been proposed to re-attach the vagina to the ATFP using two to four non-absorbable sutures. However, based on anatomical observation, the ATFP is thin its superior part and thicker inferiorly. This is an issue that might affect the reliability of identifying and ensuring a secure anchorage to the ATFP when solely using a transvaginal route. Recently a novel. Technique of PVDR, called transobturator cystocele repair has been published. However, as the technique was described recently, no follow-up data have been reported to support its practice.

The aim of this randomized controlled trial (RCT) is to compare the novel TOCR and standard anterior colporrhaphy (AR) regarding their safety, efficacy and quality-of-life improvement in a one-year follow-up.

Вмешательства

• Процедура Transobturator cystocele repair
  Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
• Процедура Anterior colporrhaphy
  The traditional transvaginal surgery for cystocele treatment used as a comparator in the study

Первичные конечные точки

• Anatomic failure [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Composite surgery failure [Срок оценки: 1 year]
• 2-year composite surgery failure [Срок оценки: 2 years]
• 2-year anatomic failure [Срок оценки: 2 years]
• Complication rate [Срок оценки: 1 year]
• Pain after the surgery [Срок оценки: Postoperative day 14]
• Subjective perception of improvement [Срок оценки: 1 year]
• 2-year subjective perception of improvement [Срок оценки: 2 years]
• Patient satisfaction [Срок оценки: 1 year]
• De novo stress urinary incontinence (SUI) [Срок оценки: 1 year]
• De novo overactive bladder (OAB) [Срок оценки: 1 year]
• Change in quality of life - urinary incontience [Срок оценки: 1 year]
• Change in quality of life - prolapse bother [Срок оценки: 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• Malignancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 6 центров

• Faculty of Medicine in Hradec Kralove, Charles University — Hradec Králové
• Medical Faculty, Ostrava University — Ostrava-Poruba
• Hospital Pardubice Region, Inc. — Pardubice
• Faculty of Medicine in Pilsen, Charles University — Pilsen
• Hospital na Bulovce, 1st Medical Faculty, Charles University — Prague
• Tomas Bata Regional Hospital in Zlin — Zlín

Словакия · 2 центра

• Košice Medical University — Košice
• Trenčianska univerzita Alexandra Dubčeka — Trenčín

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT05602246 · STARS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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