The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery. The secondary objectives of this study are the following: 1. to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q. 2. to overall quality of life assessment and expectations of patients. 3. to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain. 4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
220
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
...and 2 more locations
PFDI-20 score
The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse
Time frame: 4 years
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