INTRODUCTION AND HYPOTHESIS: The high uterosacral vault suspension (HUVS) is a vaginal approach for treating apical prolapse that provides shorter operative and recovery times and is associated with lower morbidity rates. Success rates reported for this technique are comparable with the abdominal sacrocolpopexy (SCP); however, to date, there are no prospective randomized studies comparing HUVS to SCP. The aim of the study was to compare the anatomical objective cure rates for the apical compartment in patients undergoing either HUVS or SCP at 12 months' follow-up. METHODS: We performed a single-center parallel randomized controlled trial in patients with severe apical defect defined as Pelvic Organ Prolapse Quantification (POP-Q) point C ≥ stage 3. Based on the center's previous experience, a sample size of 124 patients was required to show a 20% cure rate difference between both techniques with 80% power and using a two-tailed 5% level of significance. One hundred and ten patients were available for analysis; 54 were allocated to abdominal SCP and 56 to HUVS. The primary outcome was to evaluate surgical objective success defined as POP-Q point C stage<2. The Pelvic Floor Distress Inventory (PFDI-20), the Perceived Quality of Life Scale (P-QOL), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) questionnaires were used for subjective assessment. RESULTS: The objective success rate for apical suspension at 12 months' follow-up was 100% for abdominal SCP and 82.5% for HUVS (log-rank p 0.033). Both techniques showed a significant improvement with regards to prolapse symptoms, quality of life (QOL), and sexual function. The significant improvement in postoperative questionnaires was comparable between both surgeries at 12 months' follow-up. CONCLUSIONS: Abdominal SCP has statistically significant better anatomical results when compared with HUVS for correcting apical defects at 12 months.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The high uterosacral vault suspension (HUVS) is a vaginal approach for treating apical prolapse that provides shorter operative and recovery times and is associated with lower morbidity rates. Success rates reported for this technique are comparable with the abdominal sacrocolpopexy (SCP); however, to date, there are no prospective randomized studies comparing HUVS to SCP. The aim of the study was to compare the anatomical objective cure rates for the apical compartment in patients undergoing either HUVS or SCP at 12 months' follow-up. METHODS: We performed a single-center parallel randomized controlled trial in patients with severe apical defect defined as Pelvic Organ Prolapse Quantification (POP-Q) point C ≥ stage 3. Based on the center's previous experience, a sample size of 124 patients was required to show a 20% cure rate difference between both techniques with 80% power and using a two-tailed 5% level of significance. One hundred and ten patients were available for analysis; 54 were allocated to abdominal SCP and 56 to HUVS. The primary outcome was to evaluate surgical objective success defined as POP-Q point C stage<2. The Pelvic Floor Distress Inventory (PFDI-20), the Perceived Quality of Life Scale (P-QOL), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) questionnaires were used for subjective assessment. RESULTS: The objective success rate for apical suspension at 12 months' follow-up was 100% for abdominal SCP and 82.5% for HUVS (log-rank p 0.033). Both techniques showed a significant improvement with regards to prolapse symptoms, quality of life (QOL), and sexual function. The significant improvement in postoperative questionnaires was comparable between both surgeries at 12 months' follow-up. CONCLUSIONS: Abdominal SCP has statistically significant better anatomical results when compared with HUVS for correcting apical defects at 12 months.
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