Prosthetic Pelvic Organ Prolapse Repair (PROSPERE)

Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.

It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

Study Overview

• Status: Completed
• Conditions: Cystocele
• Intervention / Treatment: Procedure: laparoscopic sacropexy; Procedure: vaginal mesh

Detailed Description

This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.

• Study Type: Interventional
• Enrollment (Actual): 262
• 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 Nîmes
  • 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

Description

Inclusion Criteria:

• Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse.
• Patient must have provided written informed consent form prior to enrolment
• Patient must be insured

Exclusion Criteria:

• Previous of surgery for prolapse
• Unfavourable conditions to one or other of the 2 evaluated procedure
• Pelvic malignancy in the course of evolution
• Contraindication to the use of mesh
• Women not reading French
• Patients haven't have a social insurance
• Pregnancy or desire for future pregnancy
• To be under guardianship or deprived of liberty
• Simultaneous participation in another biomedical research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic sacropexy; under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.	Procedure: laparoscopic sacropexy; under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.; Other Names: laparoscopic surgery
Experimental: vaginal mesh; after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.	Procedure: vaginal mesh; after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.; Other Names: medical vaginal device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity (Dindo Classification)	Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific complications	Comparison for the specific complications of sub-vesical mesh according to the route : Symptomatic erosions, shrinkages, infections,; Serious Adverse event	12 months
Medium-term tolerance	Comparison of both techniques for the medium-term tolerance: Sexual: sexual quality of life, de novo dyspareunia;; Urinary: urinary quality of life, urinary functional signs, urgenturia, leakage; Post-operative chronic pelvic pains	12 months
Clinical Efficiency	Comparison of both techniques for the medium-term (1 year follow-up)clinical efficiency: rate of anatomical recurrences at one year,; functional Symptoms of prolapse, general quality of life	12 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lucot 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimated): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: laparoscopic sacropexy; Stage II; coelioscopic; Randomized study; bladder prolapse (cystocele); Pelvic organ prolapse repair; prosthetic surgery; vaginal approach; vaginal mesh surgery; Clavien Dindo
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Signs and Symptoms; Cystocele; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Laparoscopy
• Other Study ID Numbers: 2011_24; 2011-A01282-39 (Other Identifier: ID-RCB number, ANSM)