The objective of this study was to determine whether anterior colporrhaphy plus insertion of anterior dermal allograft reduces anterior prolapse recurrence at 1 and 7 to 10 years postoperatively compared with anterior colporrhaphy alone.
We present a nonblinded randomized controlled trial with 1- and 7- to 10-year follow-up. Subjects were randomized between 2005 and 2008 to anterior colporrhaphy or ultralateral anterior colporrhaphy plus insertion of a dermal allograft spanning the anterior compartment between the arcus tendineus fascia pelvis on each side. Eligible subjects had anterior prolapse to the hymen or beyond, were bothered by their prolapse, and were planning to undergo surgical correction. Subjects completed a pelvic organ prolapse quantification system (POPQ) examination and Pelvic Floor Distress Inventory (PFDI)/PFDI-20 before surgery; a POPQ, PFDI, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire at 1 year postoperatively; and a POPQ, PFDI-20, Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised, and Patient-reported Global Impression of Improvement Inventory at 7 to 10 years postoperatively. Our primary outcome was anatomic anterior prolapse recurrence at 1 or 7 to 10 years defined as Aa or Ba greater than or equal to −1. Our secondary outcome was a composite score of anterior prolapse recurrence at 1 or 7 to 10 years defined as anatomic recurrence (Aa or Ba ≥ 0), retreatment for cystocele, or answering yes to PFDI-20 question 3 (subjective report of vaginal bulge).
A total of 114 subjects were randomized, 70 to anterior colporrhaphy and 44 to anterior colporrhaphy plus dermal allograft. About 92% of subjects underwent concomitant apical suspension, 98% in the graft group and 89% in the nongraft group. Eighty-nine subjects (32 graft [73%], 57 nongraft [81%]) returned for 1-year follow-up. Fifty-three patients (19 graft [48%], 34 nongraft [49%]) returned for 7- to 10-year follow-up. The primary outcome was met by 8 (18%) graft and 22 (31%) nongraft subjects at 1 year postoperatively (P = 0.26) and by 10 (23%) graft and 24 (34%) nongraft subjects at 7 to 10 years postoperatively (P = 0.37). The secondary outcome was met by 8 (18%) graft and 15 (21%) nongraft subjects at 1 year postoperatively (P = 0.74) and by 13 (30%) graft and 21 (30.0%) nongraft subjects at 7 to 10 years postoperatively (P = 0.99).
We cannot conclude whether there is a difference in anterior recurrence for anterior colporrhaphy with and without dermal allograft and do not recommend changes in clinical practice based on these results.
Our randomized trial comparing prolapse repair with a dermal allograft compared with a native tissue repair showed no short-term or long-term outcome differences, but our study was underpowered to detect these differences.
From the *North Shore University Health Systems, University of Chicago, Center for Pelvic Health, Chicago, IL;
†Kalihi-Palama Health Center, Honolulu, HI;
‡Division of Urogynecology, Department of Obstetrics and Gynecology, Albany Medical College, Albany, NY; and
§University of Texas Health Science Center, San Antonio, TX.
Correspondence: Shilpa Iyer, MD, MPH, The University of Chicago, 5841 S. Maryland Ave. MC 2050, Chicago, IL 60637. E-mail: email@example.com; Sylvia Botros, MD, MSCI, The University of Texas, San Antonio, 8300 Floyd Curl Drive, San Antonio, TX 78229.
Boston Scientific supplied the Repliform allograft product necessary to perform the study. Boston Scientific was not involved in study design, data collection, analysis, article writing, or article editing.
The authors declare no conflict of interest.