Prosthetic Pelvic Organ Prolapse Repair (PROSPERE)

University Hospital, Lille

Status: Completed

Conditions: Cystocele

Treatments: Procedure: vaginal mesh; Procedure: laparoscopic sacropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01637441

2011_24

2011-A01282-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

262 participants in 2 patient groups

laparoscopic sacropexy

Experimental group

Description:

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.

Treatment:

Procedure: laparoscopic sacropexy

vaginal mesh

Experimental group

Description:

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.

Treatment:

Procedure: vaginal mesh