Objective: To determine the efficacy of a single injection of platelet-rich plasma (PRP) into the anterior vaginal wall at the mid-urethra compared to placebo, as there is emerging evidence that PRP may help treat female stress urinary incontinence (SUI).

Methods: This was a single-blind, randomized, placebo-controlled clinical trial at a single institution. Females with bothersome, demonstrable stress-predominant urinary incontinence were enrolled. Participants were randomized to either injection of 5 mL autologous PRP or saline at the anterior vaginal wall at the mid-urethra. The primary outcome was composite treatment success at 6 months, defined as a negative cough stress test and an answer of "much better" or "very much better" on the Patient's Global Impression of Improvement.

Results: Fifty patients were enrolled in the study and randomized to the PRP group (n = 25) or the saline placebo group (n = 25). There was no statistically significant difference in the primary outcome between the 2 groups. Adverse events were minor, and the rate of adverse events was similar between both groups.

Conclusion: In this randomized placebo-controlled study, we were unable to demonstrate a difference in SUI treatment success between PRP and saline injections. At this time, there is insufficient evidence to offer a one-time PRP injection into the anterior vaginal wall for treatment of female SUI.