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Completed

NCT Number: NCT02272361

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

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).

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Key information

Conditions

Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sébatien BLANC, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic sacrocolpopexy

Other

vaginal mesh surgery

Other

Primary outcomes

  1. PFDI-20 score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up

Acronym: PROSPERE4

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2014
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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