Short and Medium-Term Results of the Autologous Adult Mucosa Stem Cell Therapy Compared with Mini-Sling Surgery in the Treatment of Women’s Stress Urinary Incontinence; A Randomized Clinical Trial

Abstract

Objective: This study aimed to compare the results of stem cell therapy with mini-sling for women’s stress urinary incontinence. Methods: This study was a parallel groups noninferiority randomized clinical trial. Patients with pure stress urinary incontinence who did not improve after three months of conservative and medical therapy were included. Patients were divided into two groups mini-sling insertion or peri-urethral injection of the autologous mucosa stem cell with simple equal randomization. Standard Incontinence Impact Questionnaire (IIQ) for patients’ satisfaction as well as objective Marshal Test as primary outcomes were compared. Results: From October 2016 to March 2018, 30 patients (mean age of 52 years) were randomly divided equally into two groups. Finally, a negative Marshal test was observed in 73% of the stem cell group vs. 80% in the mini-sling group (p = 0.6). The mean decrease in the IIQ results was 12 points in the stem cell group vs. 25 points in the mini-sling group (p = 0.05). Favorable results at 6 m and 26 m follow-up were 40% vs. 80% (p = 0.06) and 53% vs. 60% (p = 0.7) in stem cell and mini-sling group, respectively. Patients in the mini-sling group experienced a higher rate of dyspareunia. Intervention time and hospital stay were 6.46 ± 1.24 minutes vs. 19.40 ± 4.30 minutes (p = 0.001) and 4.33 ± 1.23 vs. 9.20 ± 3.16 hours (p = 0.001) in stem cell and mini-sling groups, respectively. Conclusion: Results of the periurethral injection of the autologous adult mucosa-derived stem cells are not inferior to the less invasive mini-sling procedure; while, the stem cell group showed shorter intervention time and hospital stay as well as fewer complications. This noninferiority pilot randomized trial compared the results of stem cell therapy with mini-sling surgery and showed that in the medium-term followup, the results are comparable. Clinical Trial Registration Number: IR.KMU.REC.1395.343.