The Long-Term Results of Pubovaginal Sling Surgery Using Acellular Cross-Linked Porcine Dermis in the Treatment of Urodynamic Stress Incontinence

Abstract

Acellular cross-linked porcine dermis is a potential substitute for rectus fascia as a sling material with the advantage of decreased morbidity. However, the long-term efficacy is unknown. We compared the 3-year efficacy of PD vs autologous rectus fascia as a sling material for pubovaginal sling surgery in the treatment of urodynamic stress incontinence. Between July 2000 and December 2001 a total of 101 consecutive, nonrandomized patients with USI underwent a PD (51) or RF (50) sling procedure. Patients were assessed at 6 weeks, and at 3, 6 and 12 months postoperatively. Urodynamic study was repeated in cases of treatment failure. A detailed survey questionnaire was mailed to all patients at least 36 months after surgery and all responders were then retested by telephone interview by a blinded assessor. The primary outcome measure was patient perceived success rate (cured or improved) at least 36 months after PVS. Secondary outcome measures were patient satisfaction 36 months after surgery, durability of success with time and reoperation rate. Complete data were available on 94 patients (48 treated with PD and 46 treated with RF sling). The groups were well matched for age, leak point pressure, prior incontinence surgery and urge symptoms. Pubovaginal sling was successful (cured or improved) in 37 (80.4%) patients treated with RF but in only 26 (54%) patients treated with PD 36 months after surgery (Fisher's exact test p = 0.009; 95% CI 8.03, 44.4). Treatment failure occurred by 9 months after RF and by 24 months after PD sling procedure. Repeat urodynamic study showed USI to be the cause of treatment failure in 18 (37.5%) of 20 patients treated with PD but in only 3 (6.5%) of 8 patients treated with RF. We have shown that use of the PD sling, although reducing early morbidity, results in a significantly inferior long-term cure rate in comparison to the RF sling. Therefore, acellular cross-linked porcine dermis should not be used as a substitute for rectus fascia.