This secondary outcome will be evaluated 1, 2, and 3 years after surgery by an independent assessor blinded to the allocated arm.
The primary outcome and several secondary outcomes (items 1 and 3) will be evaluated according to a double-blind protocol (since the patient and his assessor will not be aware of the randomization arm that will have been assigned to the patient).
Comparisons will be made between the two groups of randomization in an intention-to-treat analysis. The inclusion period will extend over 30 months. The duration of follow-up for each patient will be 42 months. The trial will last 72 months.
Randomization
Patients will be randomly assigned in a 1:1 ratio in the operating room to undergo anterior colporraphy (reference treatment) or vaginal patch plastron (experimental treatment) by a remote web-based randomization system.
In case of a computer problem, a paper randomization list will be available.
Since there is no specific contraindication for any of the two techniques, both surgical treatments can be performed in all patients included in the study. Hence, patients will not be aware of randomization assignment. In contrast, masking for the surgeon with respect to treatment allocated by randomization will not be feasible.
Hysterectomy will not be performed systematically; however, in case of hysterectomy, a sacrospinous ligament fixation or a high McCall culdoplasty will be performed.
The randomization will be stratified according to the center of care and to concomitant treatment of apical prolapse.
In this trial, we aim to compare the effectiveness of vaginal patch plastron versus anterior colporraphy at 1 year after surgery in patients with symptomatic cystocele. Therefore, both procedures will be standardized for all the surgeons in all participating centers. Standardization will be made through broadcasting video of surgical techniques and by performing, if necessary, double-team surgeries during implementation of the protocol.
Experimental arm A: vaginal patch plastron
We will delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The upper edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be opened wide to highlight the tendinous arches. The vaginal plastron will be tied to the tendinous arch of the pelvic fascia by three lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. Then the plastron will be tensioned and the cystocele will be suspended. Vaginal wall closure will end the procedure.
Active control arm B: anterior colporraphy
We will 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. Vaginal wall closure will end the procedure.
Approved associated surgical procedures
Approved associated surgical procedures comprise total hysterectomy with sacrospinous fixation or a high McCall culdoplasty, stress urinary incontinence cure, and rectocele repair by plication of the pre-rectal fascia.
In case of indication of associated hysterectomy or of prolapse of the vaginal fundus, a sacrospinofixation of Richter or a high McCall culdoplasty will be performed. In contrast, myorraphy of levator ani muscles cannot be conducted at the time of cystocele repair because of the higher rates of post-operative pain and dyspareunia associated with such a procedure.
Patients’ follow-up will comprise:
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A visit 45 days (± 10 days) after surgery to evaluate the post-operative complications according to the Clavien-Dindo classification (referent surgeon);
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Two additional visits at 4 and 8 months (± 1 week) after surgery to make sure they have not suffered from delayed post-operative complications. Both visits will be managed by a clinical research associate through a telephone call;
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A visit 1 year (± 2 weeks) after surgery to evaluate the primary outcome (anatomical and functional success) managed by an independent assessor blinded to the type of surgery;
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A visit 2 years (± 2 weeks) after surgery to evaluate the failure rate of POP surgery with anatomical and functional failures managed by an independent assessor blinded to the type of surgery;
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A visit 3 years (± 2 weeks) after surgery to evaluate the failure rate of POP surgery with anatomical and functional failures managed by an independent assessor blinded to the type of surgery.
Inclusion criteria will be:
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Age ≥ 50 years
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Symptomatic primary prolapse of the anterior vaginal wall with Aa and/or Ba points ≥ 0 according to the POP-Q system
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A positive answer 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)
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Ability to give informed consent
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Performance status score ≤ 2
Exclusion criteria will be:
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Indication of concomitant myorraphy of levator ani muscles
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History of previous surgical cystocele repair
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Currently evolving gynecologic cancer
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Pregnancy or wish for future pregnancy, lactating woman
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Inability to participate in study follow-up or to provide informed consent or under judicial protection
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Lack of social insurance
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Contraindication of surgical treatment of prolapse
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Inability to read French
Sample size
The estimated number of required participants is based on the primary outcome. We estimate that the rate of success defined by combined objective and subjective measures of the anterior colporraphy is about 45% at 1 year, with anatomical success defined with Aa and Ba point of 0 [
6,
12].
Vaginal patch plastron technique has never been studied with a combined definition of success (anatomical and functional). Its reported anatomical success rate ranges from 93 to 98% while its functional success rate ranges from 74 to 92% [
16]. This procedure combines the advantages of techniques used for the management of median and lateral cystoceles. Therefore, we hypothesize that vaginal patch plastron will be more effective than anterior colporraphy regarding the primary outcome. Sample size calculation is based on an expected difference of 20% in the rate of success as defined by the primary outcome. Calculations with alpha = 5% and beta = 20% yielded 96 patients per group. Assuming a 10% rate of lost-to-follow-ups at 1 year, we have planned to include a total of 214 women (107 patients per treatment arm).
To date, 8 centers are participating in the study. We expect to enroll 90 patients per year. With an inclusion period of 30 months, we are hoping for a total of 225 inclusions.