CompletedNot Applicable

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

France220 participantsStarted 2014-10

Plain-language 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).

Who can participate

Age range45 Years – 75 Years

SexFEMALE

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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

What they're measuring

PFDI-20 score

Timeframe: 4 years

Trial details

NCT IDNCT02272361

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-20

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