Prosthetic Pelvic Organ Prolapse Repair

NACompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

November 30, 2015

Conditions
Cystocele
Interventions
PROCEDURE

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.

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.

Trial Locations (12)

17019

CH La Rochelle Service de Gynécologie Obstétrique, La Rochelle

30029

CHU de Nîmes, Nîmes

59037

CHRU de Lille - Service de Gynécologie médico chirurgicale, Lille

59760

GCS Flandre Maritime, Grande-Synthe

63003

CHU Estaing, Clermont-Ferrand

67000

Hôpital de Hautepierre, Strasbourg

74374

Sébatien BLANC, Annecy

75571

Groupe Hospitalier Diaconesses Croix St-Simon, Paris

78303

CHI Poissy-St-Germain / Service de gynécologie, Poissy

86000

CHU de Poitiers, Poitiers

92140

Hôpital Antoine Béclère, Clamart

94275

Hôpital BICETRE / Service de Gynécologie Obstétrique, Le Kremlin-Bicêtre

All Listed Sponsors
lead

University Hospital, Lille

OTHER

NCT01637441 - Prosthetic Pelvic Organ Prolapse Repair | Biotech Hunter | Biotech Hunter