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

University Hospital, Lille

Status

Completed

Conditions

Cystocele

Treatments

Other: vaginal mesh surgery

Other: laparoscopic sacrocolpopexy

Study type

Interventional

Funder types

Other

Identifiers

NCT02272361

2014-A00258-39 (Other Identifier)

2014_03

Details and patient eligibility

About

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:

to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
to overall quality of life assessment and expectations of patients.
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.
to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).

Enrollment

220 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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