Contemporary comparison between retropubic midurethral sling and autologous pubovaginal sling for stress urinary incontinence after the FDA advisory notification.

OBJECTIVE

To compare the efficacy and safety in a contemporary cohort of women who were offered either a pubovaginal sling (PVS) or a synthetic midurethral sling (MUS) after the U.S. Food and Drug Administration notification and made an informed decision on procedure option.

METHODS

A total of 201 women were given the option between a PVS and an MUS. Prior anti-incontinence surgery and concomitant surgery other than hysterectomy were not allowed. Minimal follow-up was 12 months. Patients were prospectively followed with validated quality of life questionnaires. Cure, voiding complaints, and complications were compared between the groups.

RESULTS

Ninety-one women (45%) underwent PVS and 110 underwent MUS (55%). Median follow-up was 13.8 months. There was no difference in baseline characteristics between the groups except for the prevalence of urge incontinence. Subjective improvement in questionnaire scores was significant for both groups. Cure rate was accomplished in 75.8% of the PVS group patients compared with 80.9% of the MUS group patients (hazard ratio, 1.35; 95% confidence interval, 0.69-2.7; P = .38). Complications and voiding difficulty were similar between the groups.

CONCLUSION

In this contemporary cohort of women considered suitable candidates for either a PVS or an MUS, both offer comparable efficacy and complication rates. PVS may be safely offered to patients who would otherwise be good candidates for MUS if they are concerned with the implantation of mesh.