CompletedNot Applicable

Prosthetic Pelvic Organ Prolapse Repair

France262 participantsStarted 2012-09

Plain-language summary

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders. It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

Who can participate

Age range45 Years – 75 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse. * Patient must have provided written informed consent form prior to enrolment * Patient must be insured Exclusion Criteria: * Previous of surgery for prolapse * Unfavourable conditions to one or other of the 2 evaluated procedure * Pelvic malignancy in the course of evolution * Contraindication to the use of mesh * Women not reading French * Patients haven't have a social insurance * Pregnancy or desire for future pregnancy * To be under guardianship or deprived of liberty * Simultaneous participation in another biomedical research

What they're measuring

Morbidity (Dindo Classification)

Timeframe: 12 months

Trial details

NCT IDNCT01637441

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Cystocele trials