Clinical trial NCT02272361: Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystocele
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 220
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility 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

Primary outcomes:
measure: PFDI-20 score
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Annecy
country: France
facility: Sébatien BLANC
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Grande Synthe
country: France
facility: GCS Flandre Maritime
city: La Rochelle
country: France
facility: CH La Rochelle Service de Gynécologie Obstétrique
city: Le Kremlin Bicêtre
country: France
facility: Hôpital BICETRE / Service de Gynécologie Obstétrique
city: Lille
country: France
facility: CHRU de Lille - Service de Gynécologie médico chirurgicale
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix St-Simon
city: Poissy
country: France
facility: CHI Poissy-St-Germain / Service de gynécologie
city: Poitiers
country: France
facility: CHU de Poitiers
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
Study officials:
affiliation: University Hospital, Lille
name: Jean-Philippe LUCOT, MD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lucot JP, Fritel X, Debodinance P, Bader G, Cosson M, Giraudet G, Collinet P, Rubod C, Fernandez H, Fournet S, Lesavre M, Deffieux X, Faivre E, Trichot C, Demoulin G, Jacquetin B, Savary D, Botchorichvili R, Campagne Loiseau S, Salet-Lizee D, Villet R, Gadonneix P, Delporte P, Ferry P, Aucouturier JS, Thirouard Y, de Tayrac R, Fatton B, Wagner L, Nadeau C, Wattiez A, Garbin O, Youssef Azer Akladios C, Thoma V, Baulon Thaveau E, Saussine C, Hermieu JF, Delmas V, Blanc S, Tardif D, Fauconnier A; GROG (groupe de recherche en gynecologie et obstetrique). [PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. J Gynecol Obstet Biol Reprod (Paris). 2013 Jun;42(4):334-41. doi: 10.1016/j.jgyn.2013.03.012. Epub 2013 Apr 22. French.