Prosthetic Pelvic Organ Prolapse Repair

Not Applicable

Completed

• Conditions: Cystocele
• Interventions: Procedure: laparoscopic sacropexy; Procedure: vaginal mesh

• Registration Number: NCT01637441
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-11
• Study Start: 2012-09
• Primary Completion: 2015-07
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic sacropexy	laparoscopic sacropexy	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 mesh	vaginal mesh	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.

Primary Outcome Measures

Name	Time	Method
Morbidity (Dindo Classification)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Specific complications	12 months	Comparison for the specific complications of sub-vesical mesh according to the route : * Symptomatic erosions, shrinkages, infections,; * Serious Adverse event
Medium-term tolerance	12 months	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
Clinical Efficiency	12 months	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

Trial Locations

Locations (12)

CHU Estaing; 🇫🇷 Clermont Ferrand, France

GCS Flandre Maritime; 🇫🇷 Grande Synthe, France

Hôpital BICETRE / Service de Gynécologie Obstétrique; 🇫🇷 Le Kremlin Bicêtre, France

CH La Rochelle Service de Gynécologie Obstétrique; 🇫🇷 La Rochelle, France

CHU de Nîmes; 🇫🇷 Nîmes, France

Groupe Hospitalier Diaconesses Croix St-Simon; 🇫🇷 Paris, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHU de Poitiers; 🇫🇷 Poitiers, France

Sébatien BLANC; 🇫🇷 Annecy, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

CHRU de Lille - Service de Gynécologie médico chirurgicale; 🇫🇷 Lille, France

CHI Poissy-St-Germain / Service de gynécologie; 🇫🇷 Poissy, France