Prosthetic Pelvic Organ Prolapse Repair (PROSPERE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01637441
First received: July 6, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Cystocele
Procedure: laparoscopic sacropexy
Procedure: vaginal mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Morbidity (Dindo Classification) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Specific complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Comparison for the specific complications of sub-vesical mesh according to the route :

    • Symptomatic erosions, shrinkages, infections,
    • Serious Adverse event

  • Medium-term tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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

  • Clinical Efficiency [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 262
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: medical vaginal device

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637441

Locations
France
Sébatien BLANC
Annecy, France, 74374
Hôpital Antoine Béclère
Clamart, France, 92140
CHU Estaing
Clermont Ferrand, France, 63003
GCS Flandre Maritime
Grande Synthe, France, 59760
CH La Rochelle Service de Gynécologie Obstétrique
La Rochelle, France, 17019
Hôpital BICETRE / Service de Gynécologie Obstétrique
Le Kremlin Bicêtre, France, 94275
CHRU de Lille - Service de Gynécologie médico chirurgicale
Lille, France, 59037
CHU de Nîmes
Nîmes, France, 30029
Groupe Hospitalier Diaconesses Croix St-Simon
Paris, France, 75571
CHU Bichat
Paris, France, 75018
CHI Poissy-St-Germain / Service de gynécologie
Poissy, France, 78303
CHU de Poitiers
Poitiers, France, 86000
Hôpital de Hautepierre
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Jean-Philippe LUCOT, MD CHRU de LILLE
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01637441     History of Changes
Other Study ID Numbers: 2011_24, 2011-A01282-39
Study First Received: July 6, 2012
Last Updated: October 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Lille:
bladder prolapse (cystocele)
Pelvic organ prolapse repair
coelioscopic
prosthetic surgery
vaginal approach
Randomized study
laparoscopic sacropexy
vaginal mesh surgery
Stage II
Clavien Dindo

Additional relevant MeSH terms:
Cystocele
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Prolapse
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014