Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair. (PROSPERE4)

Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up

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 Overview

• Status: Completed
• Conditions: Cystocele
• Intervention / Treatment: Other: laparoscopic sacrocolpopexy; Other: vaginal mesh surgery

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annecy, France, 74374
    • Sébatien BLANC
  • Clamart, France, 92140
    • Hôpital Antoine Béclère
  • Clermont Ferrand, France, 63003
    • Chu Estaing
  • Grande Synthe, France, 59760
    • GCS Flandre Maritime
  • La Rochelle, France, 17019
    • CH La Rochelle Service de Gynécologie Obstétrique
  • Le Kremlin Bicêtre, France, 94275
    • Hôpital BICETRE / Service de Gynécologie Obstétrique
  • Lille, France, 59037
    • CHRU de Lille - Service de Gynécologie médico chirurgicale
  • Nîmes, France, 30029
    • CHU de Nimes
  • Paris, France, 75571
    • Groupe Hospitalier Diaconesses Croix St-Simon
  • Poissy, France, 78303
    • CHI Poissy-St-Germain / Service de gynécologie
  • Poitiers, France, 86000
    • CHU de Poitiers
  • Strasbourg, France, 67000
    • Hopital de Hautepierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:
• Written informed consent
• insured under the French social security system

Exclusion Criteria:

• Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
• Participation in another trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: laparoscopic sacrocolpopexy	Other: laparoscopic sacrocolpopexy
Other: vaginal mesh surgery	Other: vaginal mesh surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Jean-Philippe LUCOT, MD,, University Hospital, Lille

Publications and helpful links

General Publications

• Lucot JP, Fritel X, Debodinance P, Bader G, Cosson M, Giraudet G, Collinet P, Rubod C, Fernandez H, Fournet S, Lesavre M, Deffieux X, Faivre E, Trichot C, Demoulin G, Jacquetin B, Savary D, Botchorichvili R, Campagne Loiseau S, Salet-Lizee D, Villet R, Gadonneix P, Delporte P, Ferry P, Aucouturier JS, Thirouard Y, de Tayrac R, Fatton B, Wagner L, Nadeau C, Wattiez A, Garbin O, Youssef Azer Akladios C, Thoma V, Baulon Thaveau E, Saussine C, Hermieu JF, Delmas V, Blanc S, Tardif D, Fauconnier A; GROG (groupe de recherche en gynecologie et obstetrique). [PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. J Gynecol Obstet Biol Reprod (Paris). 2013 Jun;42(4):334-41. doi: 10.1016/j.jgyn.2013.03.012. Epub 2013 Apr 22. French.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Hernia; Cystocele
• Other Study ID Numbers: 2014_03; 2014-A00258-39 (Other Identifier: ID-RCB number, ANSM)