Penile Rehabilitation in Patients With Erectile Dysfunction After Pelvic Fracture Urethral Injury Using Low-intensity Shock Wave: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from Baseline in penile doppler parameter PSV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
研究概览
简要总结
the efficacy and safety of low intensity shock wave therapy (LiSWT) as an ED treatment. Olsen et al. demonstrated that LiSWT might be a possible solution in some ED patients of organic origin . The clinical results revealed that LiSWT was beneficial to ED patients nonresponsive to phosphodiesterase type 5 inhibitors (PDE5i) Animal studies revealed that LiSWT significantly improved ischemic muscle hemodynamics and might restore pathological changes in rats .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient with erectile dysfunction post pelvic fracture associated with urethral injury as estimated via urethrography or endoscopy, managed by urethroplasty and proceed for LiSWT sessions, 3 months post operative.
- •Age 18-70 years.
- •Patient is able and willing to sign informed consent & complete all study requirements.
排除标准
- •Previous hypospadias surgery.
- •Previous surgery for congenital curvature or Peyronie's disease.
- •Previous pelvic irradiation therapy.
- •Known grave psychiatric disorder.
- •Haemophilia or any other clotting disorder that causes bleeding diathesis.
- •Use of medication to increase erectile function, such as phosphodiesterase type 5 inhibitors and intracavernous injections, during the study.
- •Other causes of erectile dysfunction either physical causes as diabetes mellitus, hypertension, cardiovascular disease & emotional causes.
- •Any condition or situation that, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or could interfere significantly with the patient's participation in the study.
研究组 & 干预措施
Effect of LISWT on EHS, IIEF score & penile doppler
干预措施: ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction (Device)
结局指标
主要结局
Change from Baseline in penile doppler parameter PSV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
时间窗: 2 years
Peak Systolic Velocity (PSV) will be measured via penile Doppler to evaluate arterial inflow. Hemodynamic recovery is indicated by increased PSV. Unit of Measure: cm/s
次要结局
- Change from the baseline of International Index of Erectile Function (IIEF) Score at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).(2 years.)
- Change from the baseline of Erectile Hardness Scale (EHS) at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).(2 years.)
- Change from Baseline in penile doppler parameter EDV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).(2 years.)
- Change from Baseline in penile doppler parameter RI at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).(2 years)
研究者
Mohammed Talaat
Dr. Mohammed Talaat, Assistant Lecturer of Urology, Faculty of Medicine, South Valley University, principle investigator, clinical assistant lecturer.
South Valley University