Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Patient reported sexual function
研究概览
简要总结
This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether LiSWT following nerve-sparing radical prostatectomy (NS-RP) improves outcomes in men with erectile dysfunction (ED) supported by cGMP phosphodiesterase inhibitor (PDE5i) medication.
SECONDARY OBJECTIVES:
I. To determine whether LiSWT improves duplex doppler ultrasound (DDUS) flow parameters at 6 months following LiSWT treatment.
II. To determine the postoperative durability of any beneficial outcome of LiWST treatment to erectile function.
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
- None
盲法说明
No Data Available
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Men aged 18-80 diagnosed with localized prostate cancer
- •Score 12 or higher on the pre-operative International Index of Erectile Function (IIEF) assessment
- •Undergo the nerve-sparing radical prostatectomy procedure
- •Be taking PDE5i medication for the entirety of the study (normal course of care)
- •Be in a sexual relationship with a partner for at least 3 months
- •Be willing to attempt sexual activity during the screening period and before each follow-up visit
- •Be willing to stop all erectile aids (e.g. prescription and non-prescription erectile medications not part of this study, penile injections, vacuum erection devices, constriction rings) during the screening and study period
排除标准
- •• Subject does not speak or understand English
- •Subject has been treated with acoustic wave previously
- •Subject has had prior penile surgery
- •Patients with pacemakers or implantable defibrillators
- •Patients who are using devices which are sensitive to electromagnetic radiation
- •Patients who are found to have metastatic disease and require radiation/hormone therapy before initiation of shockwave/sham treatments
- •Subject has lesions or active infections on the penis or perineum
- •Subject is unwilling to remove piercings from the genital region
- •Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week
- •Subject has received an investigational drug within 30 days prior to signing consent
- •Subject has received platelet-rich plasma (PRP) within 3 months of signing consent
- •Subject has received stem cell within 6 months of signing consent
- •Subject has any condition or exhibits behavior that indicates to the principle investigator (PI) that the subject is unlikely to be compliant with study procedures and visits
- •Cognitively/decisionally-impaired individuals
结局指标
主要结局
Patient reported sexual function
时间窗: At 6 months post low intensity shockwave therapy (LiSWT) initiation
Will be assessed using the International Index of Erectile Function (IIEF) The IIEF is a15-item questionnaire - each item scored from 0 to 5 - examines five main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.
次要结局
- Change in duplex doppler ultrasound measurement(Baseline to 6 months post LiSWT initiation)
- Erectile function(At 12 month following LiSWT initiation)