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.

Trial registration: ClinicalTrials.gov NCT05112718.