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
Apisith Saraluck, Orawee Chinthakanan, Athasit Kijmanawat, Komkrit Aimjirakul, Rujira Wattanayingcharoenchai, Jittima Manonai
Abstract
IMPORTANCE: Autologous 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. OBJECTIVE: The 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. DESIGN: Randomized clinical trial, single-blind assessment. SETTING: Urogynecology clinic at a tertiary medical center. PARTICIPANTS: Women 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. INTERVENTIONS: Two 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 MEASURES: The 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. RESULTS: Data 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 RELEVANCE: A-PRP + PFMT could be a treatment option for women with SUI. Large Phase III randomized controlled trials are required to confirm our findings.