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Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.
Sponsor: University Hospital, Lille
Summary
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).
Official title: Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up
Key Details
Gender
FEMALE
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2014-10
Completion Date
2018-06-20
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
laparoscopic sacrocolpopexy
vaginal mesh surgery
Locations (12)
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