Here is the design of a clinical trial:

Official Title: Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Included conditions:
- Prolapse, Vaginal

Study Armgroups:
- {'label': 'Arm A', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Anterior colporraphy']}
- {'label': 'Arm B', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: vaginal patch plastron']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Anterior colporraphy', 'description': '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.', 'armGroupLabels': ['Arm A']}
- {'type': 'PROCEDURE', 'name': 'vaginal patch plastron', 'description': '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.', 'armGroupLabels': ['Arm B']}

Primary Outcomes:
- {'measure': 'Rate of the prolapse surgery', 'description': 'The success rate of the prolapse surgery defined by a composite of objective and subjective measures:\n\n* Anatomic success defined by Aa and Ba values \\<0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND\n* Subjective success through reliable condition-specific quality-of-life questionnaires:\n\n  * 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\n  * Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND\n* No need for other treatment for prolapse (surgical nor medical)', 'timeFrame': '1 year'}

Please estimate the sample size based on the assumption: 
Calculations are based on a significance level (alpha) of 5% and a power (beta) of 80%. A 10% rate of lost-to-follow-ups at 1 year is assumed.
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 1Â 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 alphaâ=â5% and betaâ=â20% yielded 96 patients per group. Assuming a 10% rate of lost-to-follow-ups at 1Â 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 30âmonths, we are hoping for a total of 225 inclusions.