A Randomized Double-blind, Placebo-controlled Trial of Adipose-derived Regenerative Cells Injected Into Corpora Cavernosum Following Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
The goal of this study was to investigate if adipose derived regenerative cells can be used as a treatment for erectile dysfunction following radical prostatectomy.
70 participants were enrolled in the study and was performed as a double- blinded study. 35 participants in the active study arm recieved an injection into the penis of adipose derived regenerative cells, while the participants of the placebo arm recieved a placebo injection.
All 70 participants undervent liposuccion of the abdomen to harvest the adipose derived regenerative cells, and the 35 participants in the active study arm recieved their own regenerative cells.
All participants answered the questionnaires International-Index-of- Erectile function 5 and Erection Hardness Scale before treatment and after 1,3,6 and 12 months. These data was used to evaluate the effect of one injection of adipose derived regenerative cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Nervesparing robot assisted RP
- •Erectile dysfunction for more than a year after RP
- •Normal erectile function before RP (IIEF-5 > 22) and postoperative IIEF-5 score 5-20 or EHS 1
- •Involved in a monogamous, heterosexual relationship (since questionnaires are only valid for heterosexual relationsships), where both parts are interested in sexual activities
- •Insufficient effect of standard medical treatment for ED
- •Subcutaneous adipose deposits on the abdomen > 120 mL
- •Performance status 0
- •Ability to give informed consent
- •Proficiency in the Danish language to understand the questionnaires IIEF-5 and EHS
排除标准
- •Problems with general anesthesia
- •Incontinence after RP
- •Anti-thrombotic treatment that cannot be discontinued or substituted with heparin
- •No interest in sexual interaction with a partner
- •Previous pelvic surgery or radiation
- •Systemic autoimmune disease
- •Alcohol or drug abuse