Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Not Applicable

Recruiting

• Conditions: Cystocele and Incomplete Uterovaginal Prolapse; Pelvic Organ Prolapse; Cystocele

• Registration Number: NCT05602246
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-02
• Study Start: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-11
• Last Update Posted: 2023-02-14
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 592

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Composite surgery failure	1 year	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	2 years	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	2 years	Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. POPQ point Ba, or C of \> -1)
Complication rate	1 year	Number of complications Dindo-Clavien Grade \> 2
Pain after the surgery	Postoperative day 14	visual analog scale (VAS) ≥ 3 (range 0-10, higher is worse)
Subjective perception of improvement	1 year	Patient global impression of improvement (PGI-I) ≤ 2 (range 1-7, higher is worse)
2-year subjective perception of improvement	2 years	PGI-I ≤ 2 (range 1-7, higher is worse)
Patient satisfaction	1 year	Subjectively assessed by the patient on a scale 0 - 100%. Satisfaction with the surgery ≥ 80 %.
De novo stress urinary incontinence (SUI)	1 year	Any new stress leaks of urine reported by the patient ≥ once a week, or treatment
De novo overactive bladder (OAB)	1 year	de novo OAB ≥ once a week, or treatment
Change in quality of life - urinary incontience	1 year	assessed by Urinary Distress Inventory (UDI-6) score, range 0-100, higher is worse
Change in quality of life - prolapse bother	1 year	assessed by Pelvic Organ Prolapse Distress Inventory (POPDI-6) score, range 0-100, higher is worse
Change in quality of life - anorectal problems	1 year	assessed by Colorectal-Anal Distress Inventory (CRADI-8) score,range 0-100, higher is worse.
Change in quality of sexual life	1 year	assessed by Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) single summary score in sexually active women (higher is better)
Change in severity of urinary incontinence	1 year	assessed by International Consultation of Incontinence Questionnaire - Short Form (ICIQ-UI SF) score (0-21, higher is worse)

Trial Locations

Locations (8)

Faculty of Medicine in Hradec Kralove, Charles University; 🇨🇿 Hradec Králové, Czechia

Medical Faculty, Ostrava University; 🇨🇿 Ostrava-Poruba, Czechia

Hospital Pardubice Region, Inc.; 🇨🇿 Pardubice, Czechia

Faculty of Medicine in Pilsen, Charles University; 🇨🇿 Pilsen, Czechia

Hospital na Bulovce, 1st Medical Faculty, Charles University; 🇨🇿 Praha, Czechia

Tomas Bata Regional Hospital in Zlin; 🇨🇿 Zlín, Czechia

Košice Medical University; 🇸🇰 Košice, Slovakia

Trenčianska univerzita Alexandra Dubčeka; 🇸🇰 Trenčín, Slovakia