Autologous platelet rich plasma (A‐PRP) combined with pelvic floor muscle training for the treatment of female stress urinary incontinence (SUI): A randomized control clinical trial

Abstract

AbstractImportanceAutologous platelet‐rich plasma (A‐PRP) injection is a novel intervention for stress urinary incontinence (SUI) in women. However, no Phase II clinical trial has compared the outcomes of A‐PRP injection combined with pelvic floor muscle training (PFMT) with those of PFMT alone in these women.ObjectiveThe primary aim was to compare the efficacy of A‐PRP + PFMT versus PFMT alone in women with SUI. The secondary aim was to determine any adverse effects of A‐PRP injection.DesignRandomized clinical trial, single‐blind assessment.SettingUrogynecology clinic at a tertiary medical center.ParticipantsWomen with previously untreated SUI. Women in whom there was any suspicion of urgency, those with an Overactive Bladder Symptoms Score of ≥1, and those with obesity, pelvic organ prolapse, thrombocytopenia, or coagulopathy were excluded.InterventionsTwo injections of A‐PRP were administered with a 1‐month interval between injections in the A‐PRP injection + PFMT group. Both groups received PFMT.Main Outcomes and MeasuresThe primary outcome was determined using the 1‐h pad weight test (PWT). Secondary outcomes were measured using the Incontinence Quality of Life Questionnaire, item 11 on the International Consultation on Incontinence Questionnaire‐Female Lower Urinary Tract Symptoms questionnaire, Patient Global Impression of Improvement, and the percentage subjective improvement score.ResultsData for 60 study participants were available for analysis (A‐PRP + PFMT group, n = 31; PFMT group, n = 29). The 1‐h PWT decreased significantly in the A‐PRP + PFMT group but only slightly in the PFMT group at the 5‐month follow‐up. There was a statistically significant between‐group difference in the 1‐h pad weight of about 8 g in favor of the A‐PRP + PFMT group. A statistically significant difference in symptoms of SUI measured by the questionnaires was found between the A‐PRP + PFMT group and the PFMT group at the 2‐ and 5‐month follow‐up assessments. There were no reports of adverse events following injection of A‐PRP.Conclusions and RelevanceA‐PRP + PFMT could be a treatment option for women with SUI. Large Phase III randomized controlled trials are required to confirm our findings.