Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Condition(s) studied

Investigational drug(s) / intervention(s)

Anterior colporraphy: It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.

vaginal patch plastron: It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.

Study summary

The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

Eligibility

Primary outcome measure(s)

• Rate of the prolapse surgery — 1 year
  The success rate of the prolapse surgery defined by a composite of objective and subjective measures: * Anatomic success defined by Aa and Ba values \<0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND * Subjective success through reliable condition-specific quality-of-life questionnaires: * A negative response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the Pelvic Floor Distress Inventory (PFDI-20)) AND * Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND * No need for other treatment for prolapse (surgical nor medical)

Trial sites (9)

More University Hospital, Limoges trials in France