Daneshpajooh Azar, Farsinejad Alireza, Derakhshani Ali, Mirzaei Mahboubeh, Dehesh Tania, Eslami Atefe, Pakmanesh Hamid, Sohbati Samira
Department of Urology, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran.
Cell Therapy and Regenerative Medicine Comprehensive Center, Kerman University of Medical Sciences, Kerman, Iran.
J Stem Cells Regen Med. 2022 Dec 31;18(2):43-51. doi: 10.46582/jsrm.1802008. eCollection 2022.
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.
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.
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.
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.
在本研究中，我们分析了自体肌肉衍生干细胞尿道周围注射与经尿道中段吊带术在1年随访期的治疗效果。
本随机对照临床试验针对30例压力性尿失禁（SUI）且保守治疗无效的女性患者开展，登记参与者并获得知情同意后进行。患者被分为两组，每组15人，分别接受尿道周围注射肌肉衍生干细胞（MDSCs）和经尿道中段吊带术治疗。治疗后1、3、6和12个月进行随访，使用国际尿失禁咨询委员会尿失禁简表（ICIQ-UISF）和尿失禁生活质量问卷（I-QOL）问卷、临床检查、咳嗽试验和1小时尿垫试验。在组内分析结果，然后在两组之间进行比较。此外，比较两组术后并发症情况。
在1年随访时，干细胞组中，10例患者（66.6%）在尿道周围注射干细胞后症状改善；其中一半患者（33.3%）报告完全康复。在经尿道中段吊带术组，13例患者（93.3%）症状改善，12例患者（80%）报告完全康复。ICIQ-UISF和I-QOL问卷分析表明，两组的反应均显著，但干细胞组的反应明显低于标准手术组。两组均未观察到明显并发症。
尽管尿道周围注射MDSCs能显著改善SUI女性的症状且并发症最少，但其治疗反应明显低于经尿道中段吊带术。
