Prosthetic Pelvic Organ Prolapse Repair

University Hospital, Lille262 enrolled

Overview

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders. It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

262

Conditions

Cystocele

Interventions

laparoscopic sacropexyPROCEDURE

under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.

vaginal meshPROCEDURE

after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse. * Patient must have provided written informed consent form prior to enrolment * Patient must be insured Exclusion Criteria: * Previous of surgery for prolapse * Unfavourable conditions to one or other of the 2 evaluated procedure * Pelvic malignancy in the course of evolution * Contraindication to the use of mesh * Women not reading French * Patients haven't have a social insurance * Pregnancy or desire for future pregnancy * To be under guardianship or deprived of liberty * Simultaneous participation in another biomedical research

Locations (12)

Sébatien BLANC

Annecy, France

Hôpital Antoine Béclère

Clamart, France

CHU Estaing

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Morbidity (Dindo Classification)

Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.

Time frame: 12 months

Secondary Outcomes

Specific complications

Comparison for the specific complications of sub-vesical mesh according to the route : * Symptomatic erosions, shrinkages, infections, * Serious Adverse event

Time frame: 12 months

Medium-term tolerance

Comparison of both techniques for the medium-term tolerance: * Sexual: sexual quality of life, de novo dyspareunia; * Urinary: urinary quality of life, urinary functional signs, urgenturia, leakage * Post-operative chronic pelvic pains

Time frame: 12 months

Clinical Efficiency

Comparison of both techniques for the medium-term (1 year follow-up)clinical efficiency: * rate of anatomical recurrences at one year, * functional Symptoms of prolapse, general quality of life

Time frame: 12 months

Data from ClinicalTrials.gov

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