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

NCT02272361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-04-22

No results posted yet for this study

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).

Conditions

  • Cystocele

Interventions

OTHER

laparoscopic sacrocolpopexy

OTHER

vaginal mesh surgery

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Jean-Philippe LUCOT, MD, · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-06-20
Completion
2018-06-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02272361 on ClinicalTrials.gov