Comparing Periurethral Injection of Autologous Muscle-Derived Stem Cell and Fibroblasts with Mid-Urethral Sling Surgery in the Treatment of Female Stress Urinary Incontinence: A Randomized Clinical Trial.

OBJECTIVE: In this study, we analyzed the therapeutic effect of periurethral injection of autologous muscle-derived stem cell versus mid-urethral sling surgery at a 1-year follow-up.

METHOD: This randomized controlled clinical trial was conducted on 30 women with stress urinary incontinence (SUI) who had not responded to conservative treatments, after registering the participants and obtaining informed consent. Patients were divided into two groups of 15 each treated with periurethral injection of muscle-derived stem cells (MDSCs) and mid-urethral sling surgery, respectively. Follow-ups were done at 1, 3, 6, and 12 months after the treatment using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UISF) and Incontinence Quality of Life Questionnaire (I-QOL) questionnaires, clinical examination, cough test, and 1-hour pad test. The results were analyzed within the groups and then compared between the two groups. Moreover, both groups were compared in terms of postoperative complications.

RESULTS: At the 1-year follow-up, in the stem cell group, 10 patients (66.6%) experienced improvements after the periurethral injection of stem cells; half of these patients (33.3%) reported a full recovery. In the mid-urethral sling group, 13 patients (93.3%) experienced improvement, and 12 patients (80%) reported a full recovery. The analysis of ICIQ-UISF and I-QOL questionnaires indicated that the responses in both groups were significant, but the response in the stem cell group was significantly lower compared with the standard surgery group. No considerable complications were observed in the two groups.

CONCLUSION: Although the periurethral injection of MDSCs considerably improves the symptoms with minimum complications in women with SUI, its therapeutic response is significantly lower compared with mid-urethral sling surgery.