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COMPLETED
NCT02272361
NA

Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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

OTHER

laparoscopic sacrocolpopexy

OTHER

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