Benign Prostatic Hyperplasia and Ischemic Heart DIsease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Changes from the baseline 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions.
研究概览
简要总结
To examine the dynamics of 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions resulted from benign prostatic hyperplasia (BPH) with the indications for either conservative or operative treatment.
A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.
详细描述
A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients diagnosed with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.
Depending on the results of primary Holter monitoring (HM) and the method of correction (medicamentous or operative) of LUTS/BPH, all patients were subdivided into 3 groups:
Group 1 (n=20) included patients in whom primary HM revealed ECG alterations appearing or deteriorating during urination; all these patients along with recommended cardiotropic therapy, for improving impaired urination received tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow-up and treatment.
Group 2 (n=28) was composed of patients who had Holter-detected diagnostically significant ECG alterations, however, nonrelated to the act of urination; all these patients, along with the recommended cardiac therapy, in order to improve impaired urination were also received tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow up and treatment.
Group 3 (n=35) consisted of patients with BPH and IHD found to have pronounced impairments severe obstructed urination and transurethral resection of the prostate (TURP) was performed. Like in the previous group HM demonstrated diagnostically significant changes in the ECG, not however related to the act of urination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 57 Years 至 81 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •LUTS/BPH, with the total score by the IPSS more than or equal to 8;
- •Functional class II-IV angina of effort;
- •Non-ST segment depression postinfarction cardiosclerosis.
排除标准
- •Presence of cystostomic drainage;
- •Long-term LUTS/BPH therapy of prostatic hyperplasia (alpha-adrenoblockers, 5-alpha-reductase inhibitors and others) - for the groups of patients of conservative treatment of BPH;
- •Patients after operative treatment of prostatic hyperplasia (TUR of prostatic hyperplasia, transvesical adenomectomy, etc.);
- •Urinary bladder stones;
- •Acute urinary retention;
- •Changes on the ECG hampering its interpretation (complete left bundle branch block, cicatricial changes after endured myocardial infarction, permanent form of ciliary arrhythmia);
- •Acute forms of ischaemic heart disease.
研究组 & 干预措施
Tamsulosin
This group enrolled 28 patients in whom primary HM detected certain alterations (VE, SVE, ST segment depression) which did not coincide with the act of urination. The age of patients was from 57 to 81 years (mean 71.3±1.1 years). In order to improve impaired urination were also received Tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow up and treatment. Tamsulosin Oral Capsule.
干预措施: Tamsulosin Oral Capsule (Drug)
TURP
This group was composed of patients for whom after examination for symptoms of IHD and LUTS/BPH a decision was made on the necessity to perform operative treatment of BPH. TURP operation was indicated due to pronounced urination disorders which were most important amongst the patient's complaints. The patients' age varied from 59 to 77 years (mean 67.5±2.1 years).
干预措施: TURP (Procedure)
结局指标
主要结局
Changes from the baseline 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions.
时间窗: up to 6 months
Changes of the ST segment and of the cardiac rhythm during urination, which was registered by the patient by depressing the respective button on the device and keeping a diary, and totally during the whole period (24 hours) of Holter monitoring.
次要结局
未报告次要终点
研究者
Vinarov Andrey
Professor
I.M. Sechenov First Moscow State Medical University