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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272361
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : July 11, 2019
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 Phase
Cystocele Other: laparoscopic sacrocolpopexy Other: vaginal mesh surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 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
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
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


Locations
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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
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
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Principal Investigator: Jean-Philippe LUCOT, MD, University Hospital, Lille

Publications:
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02272361    
Other Study ID Numbers: 2014_03
2014-A00258-39 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Cystocele
Hernia
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical