OBJECTIVE: The aim was to determine the minimum meaningful study period required for prospective trials involving sacral colpopexy. STUDY DESIGN: This is a retrospective analysis of 245 patients who underwent sacral colpopexy. Postoperative pelvic organ prolapse quantitation was our objective end point. In an effort to control for selection bias, patients who returned for postoperative examinations were compared with those who did not for clinical and demographic information. A validated prolapse-specific quality of life instrument was used to determine the subjective end points. RESULTS: Objective failure (any postoperative POP-Q point > or = stage II) was found in 37 (15.1%) patients. Of these, 26 (70.3%) occurred within 6 months, and 30 (81.1%) occurred within 1 year. Another 5 objective failures were discovered between 1 and 2 years after surgery for a total of 94.6% of failures occurring within 2 years. There were no clinically significant differences between the groups of women with and without objective postoperative follow-up, indicating minimal selection bias. CONCLUSION: It is reasonable to construct randomized controlled trials involving sacral colpopexy that only include 1- or 2-year follow-up.
OBJECTIVE: The aim was to determine the minimum meaningful study period required for prospective trials involving sacral colpopexy. STUDY DESIGN: This is a retrospective analysis of 245 patients who underwent sacral colpopexy. Postoperative pelvic organ prolapse quantitation was our objective end point. In an effort to control for selection bias, patients who returned for postoperative examinations were compared with those who did not for clinical and demographic information. A validated prolapse-specific quality of life instrument was used to determine the subjective end points. RESULTS: Objective failure (any postoperative POP-Q point > or = stage II) was found in 37 (15.1%) patients. Of these, 26 (70.3%) occurred within 6 months, and 30 (81.1%) occurred within 1 year. Another 5 objective failures were discovered between 1 and 2 years after surgery for a total of 94.6% of failures occurring within 2 years. There were no clinically significant differences between the groups of women with and without objective postoperative follow-up, indicating minimal selection bias. CONCLUSION: It is reasonable to construct randomized controlled trials involving sacral colpopexy that only include 1- or 2-year follow-up.
Authors: Filip Claerhout; Jan Paul Roovers; Paul Lewi; Jasper Verguts; Dirk De Ridder; Jan Deprest Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2009-05-29