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

Cystocele Clinical Trial

— PROSPERE4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272361
• Other study ID #: 2014_03
• Secondary ID: 2014-A00258-39
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 20, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Hernia

Intervention

Other:
• laparoscopic sacrocolpopexy

• vaginal mesh surgery

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, 

References & Publications (1)

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 gynécologie et obstétrique). [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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFDI-20 score	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	4 years