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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Completed
• CT.gov ID: NCT02272361
• Collaborator: (none)
• Enrollment: 220
• Locations: 12
• Arms: 2
• Duration (Months): 44.6
• Patients Per Site: 18.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2014
• Actual Primary Completion Date: Jun 20, 2018
• Actual Study Completion Date: Jun 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. PFDI-20 score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sébatien BLANC	Annecy		France	74374
2	Hôpital Antoine Béclère	Clamart		France	92140
3	CHU Estaing	Clermont Ferrand		France	63003
4	GCS Flandre Maritime	Grande Synthe		France	59760
5	CH La Rochelle Service de Gynécologie Obstétrique	La Rochelle		France	17019
6	Hôpital BICETRE / Service de Gynécologie Obstétrique	Le Kremlin Bicêtre		France	94275
7	CHRU de Lille - Service de Gynécologie médico chirurgicale	Lille		France	59037
8	CHU de Nîmes	Nîmes		France	30029
9	Groupe Hospitalier Diaconesses Croix St-Simon	Paris		France	75571
10	CHI Poissy-St-Germain / Service de gynécologie	Poissy		France	78303
11	CHU de Poitiers	Poitiers		France	86000
12	Hôpital de Hautepierre	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT02272361
• Other Study ID Numbers: 2014_03; 2014-A00258-39
• First Posted: Oct 22, 2014
• Last Update Posted: Jul 11, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Cystocele; Hernia

Study Results

No Results Posted as of Jul 11, 2019