Prosthetic Pelvic Organ Prolapse Repair

Cystocele Clinical Trial

— PROSPERE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637441
• Other study ID #: 2011_24
• Secondary ID: 2011-A01282-39
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: November 3, 2015
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystocele
• Pelvic Organ Prolapse

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Sébatien BLANC	Annecy
France	Hôpital Antoine Béclère	Clamart
France	CHU Estaing	Clermont Ferrand
France	GCS Flandre Maritime	Grande Synthe
France	CH La Rochelle Service de Gynécologie Obstétrique	La Rochelle
France	Hôpital BICETRE / Service de Gynécologie Obstétrique	Le Kremlin Bicêtre
France	CHRU de Lille - Service de Gynécologie médico chirurgicale	Lille
France	CHU de Nîmes	Nîmes
France	Groupe Hospitalier Diaconesses Croix St-Simon	Paris
France	CHI Poissy-St-Germain / Service de gynécologie	Poissy
France	CHU de Poitiers	Poitiers
France	Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Specific complications	Comparison for the specific complications of sub-vesical mesh according to the route : Symptomatic erosions, shrinkages, infections,; Serious Adverse event	12 months	Yes
Secondary	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	Yes
Secondary	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	No