Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success

• Published in: American journal of obstetrics and gynecology Vol. 205; no. 1; pp. 69.e1 - 69.e8
• Main Authors: Chmielewski, Lauren, MD, Walters, Mark D., MD, Weber, Anne M., MD, MS, Barber, Matthew D., MD, MHS
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Mosby, Inc 01.07.2011; Elsevier
• Subjects: Aged; anterior colporrhaphy; Biological and medical sciences; cystocele; Female; Gynecologic Surgical Procedures - methods; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Middle Aged; Obstetrics and Gynecology; outcome measure; pelvic organ prolapse; Pelvic Organ Prolapse - surgery; Polyglactin 910 - therapeutic use; Recurrence; Treatment Outcome; treatment success; Vagina - surgery; anterior colporrhaphy; outcome measure; treatment success; cystocele; pelvic organ prolapse; Randomization; Colporrhaphy; Gynecology; Anterior; Definition; Clinical trial; Technique; Obstetrics
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2011.03.027

Objective The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success. Study Design A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996−1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤2), and (3) the absence of retreatment. Results Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes. Conclusion Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria.