Treatment of Chronic Prostatitis/ Pelvic Pain Syndrome With Low-intensity Extracorporeal Shockwave Therapy: A Prospective, Randomized, Single-blind, Cross-over Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- CPSI score
研究概览
简要总结
This study is a prospective, randomized, single-blinded, cross-over trial to investigate the efficacy of low-intensity extracorporeal shockwave therapy in the treatment of chronic pelvic pain syndrome (CPPS). We will enroll 60 subjects with Chronic Prostatitis Symptom Index (CPSI) > 15. 30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). After 3 weeks, the two groups are cross over, for additional 6 courses. The primary outcome is the the 4th week change from baseline for CPSI score. Secondary outcomes are the 8th week change from baseline for CPSI score, IIEF, QoL; AEs. The between-group relationships of baseline and 4-week data were evaluated by using the Student's t-test or Mann-Whitney U-test where appropriate. Multiple linear regression was carried out to test the variables associated with treatment outcome. P-values < 0.05 were considered statistically significant.
详细描述
Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome.
The use of LI-ESWT has been increasingly proposed as a treatment for CPPS over the last decade. Overall, most of these studies reported encouraging results, regardless of variation in LI-ESWT set-up parameters or treatment protocols. As a whole these studies suggest that LI-ESWT could significantly improve the CPSI score and pain symptoms of CPPS patients. However, no randomized control trial with cross-over designed studies so far.
This is a prospective, randomized, single-blind, cross-over clinical study. This study will be performed in outpatient setting of NTUH. Written informed consent will be given by all participants before entering the study. The subjects are treated at the therapy room of the department of urology, NTUH. All subjects would not pay any cost for this treatment/study. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).
Inclusion criteria: were patient age 20 ~ 70 year-old man, suffering from CPPS for over 3 months, and CPSI >15. The written informed consent forms from all subjects who met the inclusion criteria were obtained.
Exclusion criteria: Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression were excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
While subjects receive Sham therapy, the machine turning on but the energy is zero.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suffering from CPPS over 3 months CPSI >15
排除标准
- •Patient with prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, or known interstitial cystitis.
- •Have major depression or any major psychogenic disorders.
- •Patients with penile implant.
研究组 & 干预措施
1
30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses). Thereafter, the two groups are cross over.
干预措施: low energy extracorporeal shockwave therapy (Device)
2
30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). Thereafter, the two groups are cross over.
干预措施: low energy extracorporeal shockwave therapy (Device)
结局指标
主要结局
CPSI score
时间窗: the 4th week and the 8th week
the 4th and the 8th week change from baseline for CPSI score. 1. In the last week, have you experienced any pain / discomfort? 1. perineum 2. Testicles 3. Tip of the penis 4. pubic area 2. In the last week, have you: 1. Pain or burning during urination? 2. discomfort after sexual climax? 3. How often have you had pain over the last week? 0 Never \~ 5 Always 4. Which number describes your AVERAGE pain / discomfort over the last week? 0 \~10 5. How often have you had a sensation of not emptying your bladder completely after you finished urinating? 0 Not at all \~ 5 Almost always 6. How often have you had to urinate again \<2 hours you finished urinating? 0 Not at all \~ 5 Almost always 7. Your symptoms kept you over the last week? 0 None \~ 3 A lot 8. How much did you think about your symptoms, over the last week? 0 None \~ 3 A lot 9. If your symptoms persists during the rest of your life, how would how would you feel? 0-6
次要结局
- IIEF-5 score(the 4th week and the 8th week)
研究者
Fu-Shun Hsu
Principal Investigator
National Taiwan University