Prosthetic Pelvic Organ Prolapse Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cystocele

Intervention / Treatment
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* Procedure: laparoscopic sacropexy
* Procedure: vaginal mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic sacropexy<br>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<br>* 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.<br>* Other names: laparoscopic surgery;|
| Experimental: vaginal mesh<br>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<br>* 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.<br>* Other names: medical vaginal device;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder prolapse (cystocele), Pelvic organ prolapse repair, coelioscopic, prosthetic surgery, vaginal approach, Randomized study, laparoscopic sacropexy, vaginal mesh surgery, Stage II, Clavien Dindo