Prosthetic Pelvic Organ Prolapse Repair
PROSPERE
Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair
2 other identifiers
interventional
262
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 22, 2026
November 1, 2015
2.8 years
July 6, 2012
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Specific complications
12 months
Medium-term tolerance
12 months
Clinical Efficiency
12 months
Study Arms (2)
laparoscopic sacropexy
EXPERIMENTALunder 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.
vaginal mesh
EXPERIMENTALafter 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
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 (1)
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.
PMID: 29472143RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe LUCOT, MD
CHRU de LILLE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2012
First Posted
July 11, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2015
Study Completion
November 1, 2015
Last Updated
April 22, 2026
Record last verified: 2015-11