Platelet-Rich Plasma for the Treatment of Stress Urinary Incontinence—A Randomized Trial

Abstract

Importance Urinary incontinence affects millions of women worldwide. Objective The aim of the current study was to evaluate the efficacy and safety of periurethral platelet-rich plasma (PRP) injections in women with stress urinary incontinence (SUI). Study Design This was a single-center, double-blind, randomized sham-controlled trial. Fifty participants with SUI and urodynamic stress incontinence were randomized in 2 equally sized groups. Women in the PRP group received 2 PRP injections at 3 levels of the urethra at 4- to 6-week intervals. Women in the sham group were injected with sodium chloride 0.9%. At baseline, participants underwent urodynamic studies and a 1-hour pad test and completed the International Consultation on Incontinence Questionnaire—Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), the Patient Global Impression Scale of Improvement, and the King's Health Questionnaire. At follow-up visits (1, 3, and 6 months), women underwent the 1-hour pad test and completed the King's Health Questionnaire and the ICIQ-FLUTS. Primary outcome was the subjective evaluation as indicated by the response to question 11a of the ICIQ-FLUTS questionnaire. Secondary outcomes included scores of questionnaires and urine loss assessed on the 1-hour pad test. The level of discomfort during injections and any adverse events were also evaluated. Results During follow-up, the mean score of the 11a question decreased significantly in the PRP group compared with sham. Subjective cure was significantly higher in the PRP group (32% vs 4%, P < 0.001). A significant reduction of urine loss assessed on the 1-hour pad test was observed in the PRP group compared with the sham group at 6-month follow-up. No adverse events were observed. Conclusions Periurethral PRP injections were superior to sham injections in improving SUI symptoms with an excellent safety profile.