Clinical trial NCT01637441: Prosthetic Pelvic Organ Prolapse Repair
Official title: Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystocele
Keywords: bladder prolapse (cystocele)
Pelvic organ prolapse repair
coelioscopic
prosthetic surgery
vaginal approach
Randomized study
laparoscopic sacropexy
vaginal mesh surgery
Stage II
Clavien Dindo
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 262
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morbidity (Dindo Classification)
timeFrame: 12 months
Secondary outcomes:
measure: Specific complications
timeFrame: 12 months
measure: Medium-term tolerance
timeFrame: 12 months
measure: Clinical Efficiency
timeFrame: 12 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Sébatien BLANC
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Grande Synthe
country: France
facility: GCS Flandre Maritime
city: La Rochelle
country: France
facility: CH La Rochelle Service de Gynécologie Obstétrique
city: Le Kremlin Bicêtre
country: France
facility: Hôpital BICETRE / Service de Gynécologie Obstétrique
city: Lille
country: France
facility: CHRU de Lille - Service de Gynécologie médico chirurgicale
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix St-Simon
city: Poissy
country: France
facility: CHI Poissy-St-Germain / Service de gynécologie
city: Poitiers
country: France
facility: CHU de Poitiers
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
Study officials:
affiliation: CHRU de LILLE
name: Jean-Philippe LUCOT, MD
role: PRINCIPAL_INVESTIGATOR
References: