Vaginal Native Tissues Repair for Pelvic Organ Prolapse
ConditionProlapse, Vaginal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity Hospital, Limoges
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patient at 50 years of age or older
Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 according to the POP-Q system
A positive 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 PFDI-20)
Able to give informed consent
Disqualifiers
Patient with need for surgical treatment for myorraphy of levator ani muscles
Patient with previous surgical cystocele repair.
Patient with evolving gynaecologic cancer.
Pregnancy or wish for future pregnancy, lactating woman.
Trial design
Design model
Parallel
Treatments tested in this trial
Anterior colporraphy
Procedure/SurgeryIt 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
Procedure/SurgeryIt 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.
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: Arm AActive comparator 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of the prolapse surgery
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)
Time frame
1 yearSecondary outcomes
1
Rate of the prolapse surgery
The failure rate of the prolapse surgery defined by a composite of objective and subjective measures: * Recurrent prolapse defined by Aa and/or Ba values \> or= 0 in POP-Q OR * Subjective failure through reliable condition-specific quality-of-life questionnaires: * A positive 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 PFDI-20) OR * A PGI-I score \> 2 OR * Need of a new treatment for prolapse (surgical or medical)
Time frame
1 year2
Rate of post-operative complications
Rate of post-operative complications according to the Clavien-Dindo classification 45 days after the surgery by the patient's surgeon (not blinded)
Time frame
45 Days3
Sexual function
The sexual function improvement will be evaluated by the difference in PISQ 12 score (condition-specific quality-of-life questionnaire) between the inclusion and one year after the surgery for sexually active women
Time frame
1 year4
Rate of the prolapse surgery
The failure rate of the prolapse surgery defined by a composite of objective and subjective measures: * Recurrent prolapse defined by Aa and/or Ba values \> or= 0 in POP-Q OR * Subjective failure through reliable condition-specific quality-of-life questionnaires: * A positive 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 PFDI-20) OR * A PGI-I score \> 2 OR * Need of a new treatment for prolapse (surgical or medical)
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov