NCT03543761已完成不适用
Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial
Institute for the Study of Urological Diseases, Greece2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score
研究概览
简要总结
The aim of the study is to investigate and compare the treatment efficacy and safety of ESWT vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group sham-controlled clinical study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant must 18 to 60 years of age.
- •Participant has signed and dated the appropriate Informed Consent document.
- •Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months
排除标准
- •Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
- •Participant has a history of prostate, bladder or urethral cancer.
- •Participant has undergone pelvic radiation or systemic chemotherapy.
- •Participant has undergone intravesical chemotherapy.
- •Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.
- •Participant has undergone prostate surgery or treatment.
- •Participant with penile or urinary sphincter implants.
- •Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
- •Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
- •PI-RADS score 4-5 in the baseline prostate mpMRI
- •PI-RADS score 3, PSA>3 and age > 40 years
- •Positive (suspicious for malignancy) DRE.
结局指标
主要结局
The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score
时间窗: from baseline to 12 weeks after final treatment.
CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special pain domain (items 1-4) and the score for this domain ranges from 0 to 21.
次要结局
- The difference between the LiST and sham group in the change of IIEF-ED score(from baseline to 4 weeks after final treatment.)
- The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS)(at week 3, 4, 5, 6, 7 and 8)
- The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains(from baseline to 4 weeks after final treatment.)
- Changes in mpMRI of the prostate(baseline and 12 weeks after treatment)
- The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)(baseline, 4 and 12 weeks after final treatment)
- The difference between the LiST and sham group in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score(from baseline to 4 and 12 weeks after final treatment)
- The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score(from baseline to 4 and 12 weeks after final treatment)
- The difference between the LiST and sham group in the change of IPSS(from baseline to 4 weeks after final treatment.)
- The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR)(from baseline to 4 weeks after final treatment.)
- Adverse events rate in all patients(18 weeks)
研究者
Dimitrios Hatzichristou
President, Institute for the Study of Urological Diseases Theesaloniki, Greece
Institute for the Study of Urological Diseases, Greece
研究点 (2)
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