Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sexual Function
研究概览
简要总结
Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.
详细描述
Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. At present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. A few small studies have shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery. Low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking of probe applicator at device manufacturer before ESWT use
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 40 - 65
- •Diagnosed with low/intermediate-risk prostate cancer:
- •PSA < 20 ng/ml
- •Gleason score < 8
- •PCa stage =< T2b
- •Baseline IIEF-ED 17-30 without erectogenic aids
- •No pre-operative urinary incontinence (no usage of urinary pads)
- •Sexually active
- •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 > 5
- •Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
- •Untreated hypogonadism (serum total testosterone < 300 mg/dL)
- •Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily
- •Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
研究组 & 干预措施
Standard care + sham ESWT
Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
干预措施: Extra-corporeal shockwave therapy (ESWT) (Device)
Standard care + sham ESWT
Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
干预措施: Standard care (Other)
Standard care + active ESWT
Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
干预措施: Extra-corporeal shockwave therapy (ESWT) (Device)
Standard care + active ESWT
Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
干预措施: Standard care (Other)
结局指标
主要结局
Sexual Function
时间窗: 6 months
Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome
次要结局
- Urinary Incontinence(12 months)
- Adverse Events(12 months)
- Penile length(12 months)
研究者
Tet Yap
Principal Investigator
Guy's and St Thomas' NHS Foundation Trust