Comparing 2 Frequency Protocols of Low-intensity Shockwave Therapy for Non-bacterial Chronic Prostatitis Type IIIb /Chronic Pelvic Pain Syndrome: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 1.The difference between groups in the change of the pain domain of NIH-CPSI score
研究概览
简要总结
The study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised in 2 groups.
Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week.
Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week.
National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED) questionnaires will be answered before and at 1 and 3 month follow up visit.
Adverse events will be reported during the treatment and follow up period.
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
- Double (Investigator, Outcomes Assessor)
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.
- •PSA>3 and age > 40 years
- •Positive (suspicious for malignancy) digital rectal examination (DRE).
结局指标
主要结局
1.The difference between groups 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 groups in the change of IIEF-ED score(from baseline to 4 and 12 weeks after final treatment)
- The difference between groups in the change of total NIH-CPSI score (Q1-9)(Time Frame: baseline, 4 and 12 weeks after final treatment)
- The difference between groups 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 groups in the the Pain Visual Analogue Scale (VAS)(at week 3, 4, 5,)
- Adverse events rate in all patients(18 weeks)
- The difference between groups in the change of IPSS(from baseline to 4 and 12 weeks after final treatment)
研究者
Dimitrios Hatzichristou
President, Institute for the Study of Urological Diseases Theesaloniki, Greece
Institute for the Study of Urological Diseases, Greece