Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.
Department of Urology, Babol University of Medical Sciences, Babol, Iran.
Urol J. 2021 Oct 13;18(6):675-681. doi: 10.22037/uj.v18i.6503.
The prevalence of erectile dysfunction in men is increasing. As well, the prevalence of diabetes, as one of the causes of sexual dysfunction, is rising in many countries. Due to the failure of common therapies in some patients with sexual dysfunction, it is necessary to develop an effective alternative treatment, such as stem cell therapy, for this problem.
In this randomized single-blinded clinical trial, 20 diabetic patients with erectile dysfunction, who were resistant to common treatments, were selected and divided into two groups of intervention and control (n=10 per group). Autologous mesenchymal stem cells (MSCs) were extracted from oral mucosa and then infused via intracavernosal injection (50-60 ×106 cells) to the participants of the intervention group. Normal saline was injected in the control group. The patients were followed up with the International Index of Erectile Function (IIEF5) questionnaire, as well as color Doppler duplex ultrasound. Peak systolic velocity (PSV), end diastolic velocity (EDV), and resistance index (RI) were determined three and six months after the interventions.
The mean IIEF5 scores in the intervention group were 7.2 ± 2.1, 9.2 ± 3.4, and 10.6 ± 4.7 before, three months, and six months after the injection, respectively, showing a significant ascending trend (P = 0.01). Comparing the intervention and control groups, there was a significant difference in the IIEF5 score change during six months after the injection (P = 0.02). Regarding the PSV and RI of penis vessels, there were no statistically significant differences between the two groups. However, these parameters showed upward and improving trends in the intervention group.
Intracavernosal injection of stem cells improved sexual function and PSV and RI indices of penile arteries in diabetic patients.
男性勃起功能障碍的患病率正在上升。此外，在许多国家，糖尿病作为性功能障碍的原因之一，其患病率也在上升。由于一些性功能障碍患者对常见疗法反应不佳，因此有必要开发一种有效的替代疗法，例如干细胞疗法，来解决这个问题。
在这项随机、单盲临床试验中，选择了 20 名对常规治疗有抗药性的糖尿病勃起功能障碍患者，并将其分为干预组和对照组（每组 10 名）。从口腔黏膜中提取自体间充质干细胞（MSCs），然后通过海绵体内注射（50-60×106 个细胞）将其注入干预组患者体内。对照组患者注射生理盐水。通过国际勃起功能指数（IIEF5）问卷以及彩色多谱勒双功能超声对患者进行随访。在干预后 3 个月和 6 个月时，测定峰值收缩速度（PSV）、舒张末期速度（EDV）和阻力指数（RI）。
干预组患者的平均 IIEF5 评分分别为注射前的 7.2±2.1、3 个月后的 9.2±3.4 和 6 个月后的 10.6±4.7，呈显著上升趋势（P=0.01）。与对照组相比，注射后 6 个月时 IIEF5 评分的变化有显著差异（P=0.02）。关于阴茎血管的 PSV 和 RI，两组之间没有统计学差异。然而，这些参数在干预组中呈上升和改善趋势。
干细胞海绵体内注射可改善糖尿病患者的性功能以及阴茎动脉的 PSV 和 RI 指数。
