Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 24-month follow up
研究概览
简要总结
This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).
详细描述
This is an open-label, randomized, 2-parallel-arm trial (n=94). All patients will receive (A) sham (n=47) or (B) active ESWT (n=47) twice/week for 6 weeks (12 sessions total). Concurrently, all patients will receive daily tadalafil 5mg for 24 weeks. Patients will then undergo a 4 week washout period without erectogenic aids, and return for a 28-week evaluation. Subsequently, patients requiring further erectogenic aids after 28 weeks will be offered intracavernosal injections (ICI) of prostaglandin E1 (PGE1).
Random assignment will be performed by computer program (eg. randomizer.org), in a design that obtains equal sample size per group.
All patients will be followed for a period of 24 months post-RP. Follow-up protocol includes evaluation of the IIEF, EHS, GAQ, ICI usage and tolerability, stretched flaccid penile length, urinary incontinence, and oncologic status.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men scheduled for robotic bilateral nerve-sparing radical prostatectomy
- •Diagnosed with low/intermediate-risk prostate cancer:
- •PSA < 20 ng/ml
- •Gleason score < 8
- •PCa stage =< T2b
- •Baseline IIEF-ED 22-30 without erectogenic aids
- •No urinary incontinence (no usage of urinary pads)
- •Sexually active, in a stable heterosexual relationship
- •Able to understand and complete patient questionnaires
- •Consent to participate
排除标准
- •Anatomical abnormalities in the genitalia or pelvic region
- •Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
- •Incomplete tumor removal (positive surgical margin)
- •Tumor upstaging beyond T2b
- •Nerve sparing score < 4
- •Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
- •Untreated hypogonadism (serum total testosterone < 300 mg/dL)
- •Anti-coagulant medication, or any blood coagulation disorders (INR > 3)
- •Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
结局指标
主要结局
The difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 24-month follow up
时间窗: 24-month follow up visit
EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
The difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 28-week follow up
时间窗: 28-week follow up visit
EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
次要结局
- Change in stretched flaccid penile length(baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Change in degree of incontinence(First treatment session, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group(baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Change in Erection Hardness Score(baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, in-office ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Oncologic status(12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Change in Global Assessment Questionnaire (GAQ) score(12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Change in each domain of the full International Index of Erectile Function (IIEF) score(baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Time to recovery of penetration erection hardness without erectogenic aids(baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, in-office ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)
- Tolerability to and reliance on intracavernosal injections for satisfactory erections: Visual Analog Scale for Pain(ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP)