Sharifiaghdas Farzaneh, Zohrabi Farshad, Moghadasali Reza, Shekarchian Soroosh, Jaroughi Neda, Bolurieh Tina, Baharvand Hossein, Aghdami Nasser
Urology and Nephrology Research Center (UNRC), Department of Urology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences. Tehran, Iran.
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Urol J. 2019 Oct 21;16(5):482-487. doi: 10.22037/uj.v0i0.4736.
This clinical study evaluated the effect of autologous muscle-derived cell (MDC) injection for the treat-ment of female patients with pure stress urinary incontinence (SUI).
A total of 20 women with SUI received transurethral injections of autologous MDCs. Baseline and follow-up evaluations consisted of physical examinations (cough stress tests), one-hour pad test, In-continence Impact Questionnaire-7 (IIQ-7), and Urogenital Distress Inventory (UDI-6) scoring. The patients were followed one week as well as 1, 3, 6, 9, 12, and 24 month(s) after the procedure. Multichannel urodynamic study were performed before and 24 months after the intervention. The incidence and severity of adverse events (AE) were also recorded at each follow-up visit.
A total of 20 eligible female patients with the chief complaint of SUI that was unresponsive to conserva-tive management, was enrolled in the trial, 17 of whom completed all follow-up visits. At 12th months, 10 (59%) patients had complete response, whereas 2 (12%) and 5 (29%) patients had partial and no response, respectively. At 24th months, relapse of SUI in 5 out of 10 complete responders (29%) and 2 out of 2 partial responders to the treatment, respectively. The intervention produced no serious AE during the trial.
According to our results, though obtained from a limited number of patients, MDC therapy was a minimally invasive and safe procedure for treatment of female patients with pure SUI. However, currently, the efficacy of this type of treatment for SUI is not sufficiently high and multi-center randomized clinical trials are required to be conducted before reaching a concrete conclusion.
本临床研究评估自体肌肉衍生细胞（MDC）注射治疗女性单纯性压力性尿失禁（SUI）患者的效果。
共有20例SUI女性患者接受了经尿道自体MDC注射。基线和随访评估包括体格检查（咳嗽压力试验）、1小时尿垫试验、尿失禁影响问卷-7（IIQ-7）和泌尿生殖系统困扰量表（UDI-6）评分。术后对患者进行1周以及1、3、6、9、12和24个月的随访。干预前和干预后24个月进行多通道尿动力学研究。每次随访时还记录不良事件（AE）的发生率和严重程度。
共有20例以SUI为主诉且对保守治疗无反应的合格女性患者纳入试验，其中17例完成了所有随访。在第12个月时，10例（59%）患者完全缓解，而2例（12%）和5例（29%）患者分别部分缓解和无反应。在第24个月时，10例完全缓解者中有5例（29%）SUI复发，2例部分缓解者中有2例复发。试验期间干预未产生严重AE。
根据我们的结果，尽管患者数量有限，但MDC治疗是治疗女性单纯性SUI的一种微创且安全的方法。然而，目前这种治疗SUI的疗效不够高，在得出具体结论之前需要进行多中心随机临床试验。
