Prosthetic Pelvic Organ Prolapse Repair

NCT ID: NCT01637441

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-11-30

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.

Conditions

Cystocele

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

laparoscopic sacropexy

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

vaginal mesh

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

laparoscopic surgery; medical vaginal device

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe LUCOT, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de LILLE

Locations

Sébatien BLANC

Annecy, , France

Hôpital Antoine Béclère

Clamart, , France

CHU Estaing

Clermont-Ferrand, , France

GCS Flandre Maritime

Grande-Synthe, , France

CH La Rochelle Service de Gynécologie Obstétrique

La Rochelle, , France

Hôpital BICETRE / Service de Gynécologie Obstétrique

Le Kremlin-Bicêtre, , France

CHRU de Lille - Service de Gynécologie médico chirurgicale

Lille, , France

CHU de Nîmes

Nîmes, , France

Groupe Hospitalier Diaconesses Croix St-Simon

Paris, , France

CHI Poissy-St-Germain / Service de gynécologie

Poissy, , France

CHU de Poitiers

Poitiers, , France

Hôpital de Hautepierre

Strasbourg, , France

Countries

France

Other Identifiers

2011-A01282-39

Identifier Type: OTHER

Identifier Source: secondary_id

2011_24

Identifier Type: -

Identifier Source: org_study_id