Clinical trial NCT05602246: Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Official title: Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 592
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anatomic failure
timeFrame: 1 year
Secondary outcomes:
measure: Composite surgery failure
timeFrame: 1 year
measure: 2-year composite surgery failure
timeFrame: 2 years
measure: 2-year anatomic failure
timeFrame: 2 years
measure: Complication rate
timeFrame: 1 year
measure: Pain after the surgery
timeFrame: Postoperative day 14
measure: Subjective perception of improvement
timeFrame: 1 year
measure: 2-year subjective perception of improvement
timeFrame: 2 years
measure: Patient satisfaction
timeFrame: 1 year
measure: De novo stress urinary incontinence (SUI)
timeFrame: 1 year
measure: De novo overactive bladder (OAB)
timeFrame: 1 year
measure: Change in quality of life - urinary incontience
timeFrame: 1 year
measure: Change in quality of life - prolapse bother
timeFrame: 1 year
measure: Change in quality of life - anorectal problems
timeFrame: 1 year
measure: Change in quality of sexual life
timeFrame: 1 year
measure: Change in severity of urinary incontinence
timeFrame: 1 year
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: Faculty of Medicine in Hradec Kralove, Charles University
city: Ostrava-Poruba
country: Czechia
facility: Medical Faculty, Ostrava University
city: Pardubice
country: Czechia
facility: Hospital Pardubice Region, Inc.
city: Pilsen
country: Czechia
facility: Faculty of Medicine in Pilsen, Charles University
city: Praha
country: Czechia
facility: Hospital na Bulovce, 1st Medical Faculty, Charles University
city: Zlín
country: Czechia
facility: Tomas Bata Regional Hospital in Zlin
city: Košice
country: Slovakia
facility: Košice Medical University
city: Trenčín
country: Slovakia
facility: Trenčianska univerzita Alexandra Dubčeka
Study officials:
affiliation: Faculty of Medicine in Plzen, Charles University
name: Vladimir Kalis, prof. MD PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine in Plzen, Charles University
name: Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine in Plzen, Charles University
name: Zdenek Rusavy, assoc. prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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