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

Azar Daneshpajooh; Alireza Farsinejad; Ali Derakhshani; Mahboubeh Mirzaei; Tania Dehesh; Atefe Eslami; Hamid Pakmanesh; Samira Sohbati

doi:10.46582/jsrm.1802008

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

J Stem Cells Regen Med. 2022 Dec 31;18(2):43-51. doi: 10.46582/jsrm.1802008. eCollection 2022.

Authors

Azar Daneshpajooh¹, Alireza Farsinejad², Ali Derakhshani³, Mahboubeh Mirzaei¹, Tania Dehesh⁴, Atefe Eslami⁵, Hamid Pakmanesh¹, Samira Sohbati⁶

Affiliations

¹ Department of Urology, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran.
² Cell Therapy and Regenerative Medicine Comprehensive Center, Kerman University of Medical Sciences, Kerman, Iran.
³ Research center for hydatid disease in Iran, Kerman University of Medical Sciences, Kerman, Iran.
⁴ Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.
⁵ Urology-Nephrology Research Center, Shaheed Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
⁶ Department of Obstetrics and Gynecology, School of Medicine, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.

Abstract

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.

Keywords: Mid-urethral sling surgery; Muscle-derived stem cells (MDSCs); Periurethral injection; Quality of Life; Stress urinary incontinence.