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Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair. (PROSPERE4)

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ClinicalTrials.gov Identifier: NCT02272361
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.

The secondary objectives of this study are the following:

  1. to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
  2. to overall quality of life assessment and expectations of patients.
  3. to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.
  4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).

Condition or disease Intervention/treatment
Cystocele Other: laparoscopic sacrocolpopexy Other: vaginal mesh surgery

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up
Study Start Date : October 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
laparoscopic sacrocolpopexy
laparoscopic sacrocolpopexy
Other: laparoscopic sacrocolpopexy
vaginal mesh surgery
vaginal mesh surgery
Other: vaginal mesh surgery



Primary Outcome Measures :
  1. PFDI-20 score [ Time Frame: 4 years ]
    The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:
  • Written informed consent
  • insured under the French social security system

Exclusion Criteria:

  • Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
  • Participation in another trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272361


Contacts
Contact: Jean-Philippe LUCOT, MD +33 3 20 44 64 37 jean-philippe.lucot@chru-lille.fr
Contact: Edouard MILLOIS +33 3 20 44 59 62 ext 29210 edouard.millois@chru-lille.fr

Locations
France
Sébatien BLANC Recruiting
Annecy, France, 74374
Contact: Sébatien BLANC       sblanc1@ch-annecy.fr   
Principal Investigator: Sébatien BLANC         
Sub-Investigator: Didier TARDIF         
Hôpital Antoine Béclère Not yet recruiting
Clamart, France, 92140
Contact: Xavier DEFFIEUX       xavier.deffieux@abc.aphp.fr   
Principal Investigator: Xavier DEFFIEUX         
Sub-Investigator: Erika FAIVRE         
Sub-Investigator: Caroline TRICHOT         
Sub-Investigator: Géraldine DEMOULIN         
CHU Estaing Recruiting
Clermont Ferrand, France, 63003
Contact: Bernard JACQUETIN    +33 4 73 75 01 60    bjacquetin@chu-clermontferrand.fr   
Principal Investigator: Bernard JACQUETIN         
Sub-Investigator: Denis SAVARY         
Sub-Investigator: Revaz BOTCHORICHVILI         
GCS Flandre Maritime Recruiting
Grande Synthe, France, 59760
Contact: Philippe DEBODINANCE    +33 03 28 58 61 50    philippe.debodinance@ch-dunkerque.fr   
Principal Investigator: Philippe DEBODINANCE         
Sub-Investigator: Patrick DELPORTE         
CH La Rochelle Service de Gynécologie Obstétrique Recruiting
La Rochelle, France, 17019
Contact: Philippe FERRY    +33 5 46 45 52 19    philippe.ferry@ch-larochelle.fr   
Principal Investigator: Philippe FERRY         
Sub-Investigator: Jean-Sébastien AUCOUTURIER         
Sub-Investigator: Yannick THIROUARD         
Sub-Investigator: Emmanuelle SEC         
Hôpital BICETRE / Service de Gynécologie Obstétrique Not yet recruiting
Le Kremlin Bicêtre, France, 94275
Contact: Hervé FERNANDEZ    +33 1 45 21 77 01    herve.fernandez@bct.aphp.fr   
Principal Investigator: Hervé FERNANDEZ         
Sub-Investigator: Sandrine FOURNET         
Sub-Investigator: Magali LESAVRE         
CHRU de Lille - Service de Gynécologie médico chirurgicale Recruiting
Lille, France, 59037
Contact: Jean-Philippe LUCOT, MD    +33 3 20 44 64 37    jean-philippe.lucot@chru-lille.fr   
Sub-Investigator: Michel COSSON         
Principal Investigator: Jean-Philippe LUCOT         
CHU de Nîmes Recruiting
Nîmes, France, 30029
Contact: Renaud DE TAYRAC       renaud.detayrac@chu-nimes.fr   
Principal Investigator: Renaud De Tayrac         
Sub-Investigator: Brigitte FATTON         
Sub-Investigator: Laurent WAGNER         
Groupe Hospitalier Diaconesses Croix St-Simon Recruiting
Paris, France, 75571
Contact: Delphine SALET-LIZEE    +33 1 44 74 10 28    dlizee@hopital-dcss.org   
Principal Investigator: Delphine SALET-LIZEE         
Sub-Investigator: Richard VILLET         
Sub-Investigator: Pierre GADONNEIX         
CHI Poissy-St-Germain / Service de gynécologie Recruiting
Poissy, France, 78303
Contact: Arnaud FAUCONNIER    +33 1 39 27 52 51    afauconnier@chi-psg.com   
Principal Investigator: Arnaud FAUCONNIER         
Sub-Investigator: Georges BADER         
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Xavier FRITEL       xavier.fritel@univ-poitiers.fr   
Principal Investigator: Xavier FRITEL         
Sub-Investigator: Cédric NADEAU         
Hôpital de Hautepierre Recruiting
Strasbourg, France, 67000
Contact: Arnaud WATTIEZ       arnaud.wattiez@wanadoo.fr   
Contact: Cherif YOUSSEF AZER AKLADIOS       cherif.youssef.azer@chru-strasbourg.fr   
Principal Investigator: Arnaud WATTIEZ         
Sub-Investigator: Cherif YOUSSEF AZER AKLADIOS         
Sub-Investigator: Veronique THOMA         
Sub-Investigator: BAULON THAVEAU Emmanuelle         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Jean-Philippe LUCOT, MD, University Hospital, Lille