Penile Tissue Rehabilitation Post Nerve-sparing Radical Prostatectomy Using Low-intensity Extracorporeal Shockwave Therapy - A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving Normal Erectile Function
研究概览
简要总结
This study will investigate whether low-intensity extracorporeal shockwave therapy (LiESWT) can help men recover erectile function after nerve-sparing prostate cancer surgery. Erectile dysfunction is common after this surgery, and current rehabilitation treatments mainly help manage symptoms rather than directly promoting recovery of the affected penile tissues. LiESWT is a non-invasive treatment that uses low-intensity shockwaves and may help improve blood flow and tissue recovery.
The study will include 80 men undergoing nerve-sparing radical prostatectomy. Participants will be randomly assigned to receive either standard penile rehabilitation alone or standard rehabilitation plus eight LiESWT treatments. Erectile function, urinary function, pain, and potential side effects will be assessed throughout the 36-week study period. The main goal is to determine whether adding LiESWT increases the number of men who recover normal erectile function 24 weeks after surgery. The findings may help improve penile rehabilitation and sexual health outcomes for men recovering from prostate cancer surgery.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Scheduled to undergo nerve-sparing radical prostatectomy (NSRP), either open or robotic
- •Referred to Men's Health Clinic Manitoba (MHCM) for postoperative penile rehabilitation
- •Histologically confirmed localized prostate cancer with Gleason score <8
- •Baseline erectile function of IIEF-EF ≥17 without erectogenic aids
- •Baseline urinary function of ICIQ ≤5
- •Sexually active prior to surgery
排除标准
- •Untreated hypogonadism or serum total testosterone <300 ng/dL
- •Anatomical abnormalities of the genital or pelvic region that may interfere with treatment delivery or outcome assessment
- •Poorly controlled diabetes mellitus, defined as HbA1c exceeding acceptable surgical thresholds within three months prior to surgery
- •Any medical, psychological, or social condition that, in the investigators' opinion, would interfere with study participation or adherence to the protocol
研究组 & 干预措施
LiESWT + Standard of Care
Participants will receive standard postoperative penile rehabilitation in combination with LiESWT. LiESWT will be administered in eight treatment sessions during postoperative weeks 3-4 and 10-11, with two sessions per week, 2-3 days apart. Each approximately 15-minute session will deliver 3,000 shockwave impulses at 5 Hz and an energy flux density of 0.09 mJ/mm² to six anatomical penile treatment sites. Standard penile rehabilitation will be prescribed at the discretion of the treating physician.
干预措施: Low-Intensity Extracorporeal Shockwave Therapy (Device)
Standard of Care
Participants will receive standard postoperative penile rehabilitation as prescribed by the treating physician, without LiESWT.
干预措施: Standard of Care (Other)
结局指标
主要结局
Proportion of Participants Achieving Normal Erectile Function
时间窗: 24 weeks following nerve-sparing radical prostatectomy
The proportion of participants achieving normal erectile function will be compared between the LiESWT plus standard of care (experimental) group and the standard of care alone (control) group. Erectile function will be assessed using the 6-item International Index of Erectile Function-Erectile Function (IIEF-EF) domain. Scores range from 1 to 30, with higher scores indicating better erectile function. Normal erectile function is defined as an IIEF-EF score ≥26.
次要结局
- Change in IIEF-EF Score from Baseline(9, 12, 24, and 36 weeks following nerve-sparing radical prostatectomy)
- Change in Urinary Function(9, 12, 24, and 36 weeks following nerve-sparing radical prostatectomy)
- Pain Assessed Using the Numeric Rating Scale(9, 12, 24, and 26 weeks post nerve-sparing radical prostatectomy)
- Incidence and Severity of Adverse Events(Through 36 weeks following nerve-sparing radical prostatectomy)