Clinical Evaluation of the Efficacy and Safety of a Medical Device in the Form of Rectal Suppositories (Prospidol®) for the Treatment of Symptoms Associated With Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- reduction of NIH-CPSI score
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a medical device is effective and safe in treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in adult men.
The main questions it aims to answer are:
- Does the treatment reduce pain symptoms (measured by NIH-CPSI score) by more than 30% after one month?
- Does the treatment improve urinary symptoms, quality of life, and sexual function?
- What adverse events or side effects occur during treatment? Researchers will conduct a multicenter, open-label study involving 40 participants diagnosed with CP/CPPS. All participants will receive the same treatment, and their outcomes will be monitored over time.
Participants will:
Use one suppository daily for 10 days each month for 3 months Attend clinical visits at the start of the study and after 30, 60, and 90 days Complete validated questionnaires (NIH-CPSI, IPSS, SF-36, IIEF) at each visit Report any side effects or symptoms throughout the study At the end of the study, researchers will analyze symptom improvement, quality of life changes, and treatment tolerability.
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 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male subjects aged between 18 and 60;
- •clinical presentation typical of prostatitis and a clinical diagnosis of chronic prostatitis type IIIa or IIIb (CP/CPPS) for at least 3 months;
- •no treatment for at least 2 months;
- •PSA < 3 ng/mL;
- •digital rectal examination negative for nodules or BPH;
- •negative microbiological tests on urine and seminal fluid;
- •baseline score on the validated Italian version of the NIH-CPSI pain domain questionnaire > 7 or total NIH-CPSI score > 15;
- •digital rectal examination not suggestive of prostate cancer.
排除标准
- •patients with signs of infection and a PSA level > 3 ng/ml;
- •other active prostate conditions;
- •patients with active neoplastic, neurodegenerative or immunological conditions, those who are immunocompromised, or those who are already taking supplements or functional foods for any reason;
- •patients undergoing treatment with systemic or topical corticosteroids;
- •patients who will not sign the informed consent form;
- •patients unable to participate in a clinical trial for any reason (e.g. psychiatric patients, those with cancer, on dialysis, or with severe liver or kidney failure);
- •patients with allergies to any of the components of the medical device (MD) under investigation.
研究组 & 干预措施
Prospidol
patients enrolled in this arm will take 1 Prospidol suppository per day, to be administered before going to bed for 10 days each month, for a total period of 3 months
干预措施: Prospidol suppository (Device)
结局指标
主要结局
reduction of NIH-CPSI score
时间窗: From enrollment to the end of treatment at 4 weeks
The primary outcome of the study is the assessment of the reduction in the NIH-CPSI score after one month of treatment. Specifically, a reduction in pain symptoms of more than 30% compared with T0 is expected, given that the literature reports that patients with comparable characteristics, when treated with placebo, may experience a pain reduction of up to 30%.
Change of National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score
时间窗: From enrollment to the end of treatment at 4 weeks
The primary outcome of the study is the assessment of the change in the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI score, ranging from 0 to 43, where an improvement in symptoms is characterised by a decrease in the score) after one month of treatment. Specifically, a change in pain symptoms of more than 30% compared with T0 is expected, given that the literature reports that patients with comparable characteristics, when treated with placebo, may experience a pain reduction of up to 30%.
次要结局
- Comparison of the NIH-CPSI scores(0, 1, 2, 3 months after enrollment)
- Comparison of the SF-36 score(0, 1, 2, 3 months after enrollment)
- Comparison of the International Prostate Symptom Score (IPSS)(0, 1, 2, 3 months after enrollment)
- Comparison of the International Index of Erectile Funtion (IIEF)(0, 1, 2, 3 months after enrollment)
- Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores(0, 1, 2, 3 months after enrollment)
- Comparison of the Short Form 36 (SF-36) score(0, 1, 2, 3 months after enrollment)