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
2 other identifiers
interventional
220
1 country
12
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2018
CompletedApril 22, 2026
July 1, 2019
3.7 years
October 20, 2014
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
laparoscopic sacrocolpopexy
OTHERlaparoscopic sacrocolpopexy
vaginal mesh surgery
OTHERvaginal mesh surgery
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- insured under the French social security system
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Sébatien BLANC
Annecy, 74374, France
Hôpital Antoine Béclère
Clamart, 92140, France
CHU Estaing
Clermont-Ferrand, 63003, France
GCS Flandre Maritime
Grande-Synthe, 59760, France
CH La Rochelle Service de Gynécologie Obstétrique
La Rochelle, 17019, France
Hôpital BICETRE / Service de Gynécologie Obstétrique
Le Kremlin-Bicêtre, 94275, France
CHRU de Lille - Service de Gynécologie médico chirurgicale
Lille, 59037, France
CHU de Nîmes
Nîmes, 30029, France
Groupe Hospitalier Diaconesses Croix St-Simon
Paris, 75571, France
CHI Poissy-St-Germain / Service de gynécologie
Poissy, 78303, France
CHU de Poitiers
Poitiers, 86000, France
Hôpital de Hautepierre
Strasbourg, 67000, France
Related Publications (2)
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.
PMID: 23618743BACKGROUNDLucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizee D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19.
PMID: 29472143RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe LUCOT, MD,
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 22, 2014
Study Start
October 1, 2014
Primary Completion
June 20, 2018
Study Completion
June 20, 2018
Last Updated
April 22, 2026
Record last verified: 2019-07