Benign Prostatic Hyperplasia and Ischemic Heart DIsease
Condition: Ischaemic Heart Disease (IHD); Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS)
MeSH terms: Prostatic Hyperplasia; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.

      Criteria for inclusion into the study: 1) patient's consent; 2) absence of severe
      accompanying pathology hampering carrying out the study (mental disorders, musculoskeletal
      system diseases, oncological diseases); 3) LUTS/BPH, with the total score by the IPSS more
      than or equal to 8; 4) functional class II-IV angina of effort; 5) non-ST segment depression
      postinfarction cardiosclerosis.

      Exclusion criteria: 1) presence of cystostomic drainage; 2) long-term medicamentous therapy
      of prostatic hyperplasia (alpha-adrenoblockers, 5-alpha-reductase inhibitors and others) -
      for the groups of patients of conservative treatment of BPH; 3) patients after operative
      treatment of prostatic hyperplasia (TUR of prostatic hyperplasia, transvesical adenomectomy,
      etc.); 4) urinary bladder stones; 5) acute urinary retention; 6) "paradoxical" ischuria; 7)
      changes on the ECG hampering its interpretation (complete left bundle branch block,
      cicatricial changes after endured myocardial infarction, permanent form of ciliary
      arrhythmia); 8) acute forms of ischaemic heart disease.

      Criteria for withdrawal: voluntary refusal of the patient from further follow up;

      Beside interviewing (in the presence of angina, the patients filled in the Seattle Angina
      Questionnaire), the patients were subjected to measuring arterial pressure on both arms,
      biochemical blood analysis (measuring the level of triglycerides, cholesterol, if necessary,
      high-, low- and very-low density lipoproteins), standard 12-lead ECG. All patients in order
      to verify the diagnosis of IHD underwent detailed examination in the settings of a
      cardiological hospital including, if required, the following studies: tread-mill,
      stress-echocardiography, coronarography, multispiral computed tomography of the coronary
      arteries.

      The severity of BPH symptoms and quality of life of patients were assessed by means of the
      IPSS and QoL questionnaires. Uroflowmetry was used to determine the degree of impairments of
      urination. Besides, to specify the dimensions of the prostate, its volume and to measure the
      amount of residual urine investigators performed transabdominal ultrasound examination (if
      necessary also transcatheter ultrasound), as well as digital rectal examination and blood
      analysis for PSA and, if indicated, biopsy of the prostate to rule out cancerous prostatic
      lesion.

      The key method in the study was 24-hour ECG (Holter) monitoring using the Schiller MT 200
      device (Switzerland). Deciphering the data of 24-hour ECG monitoring, investigators examined
      the dynamics of the ST segment and changes in 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.

      Then, some patients (n=48) received therapy with tamsulosin for 30 days at a dose of 0.4 mg
      at night, and others (n=35) underwent TUR for prostatic hyperplasia. After a month on the
      background of continuing cardiac therapy and administration of tamsulosin in the group of
      conservative treatment investigators evaluated the subjective symptomatology by the IPSS and
      QoL scales, performed uroflowmetry, ultrasound examination of the prostate and the volume of
      residual urine, standard ECG and repeat 24-hour ECG monitoring with registering the time of
      urination. If necessary, the patients filled in the Seattle Angina Questionnaire again.

      All procedures performed in the study were in accordance with standard clinical care and were
      in accordance with the ethical standards of the institutional and/or national research
      committee and with the 1964 Helsinki declaration and its later amendments or comparable
      ethical standards.

      Study was approved by Sechenov University IRB. Informed consent was obtained from all
      individual participants included in the study.

      The data were processed using the methods of descriptive statistics, Student's t-test for
      paired values, in the programme BIOSTAT.
    

Intervention name(s): Tamsulosin Oral Capsule; TURP
Intervention type(s): Drug; Procedure
Intervention description(s): Tamsulosin Oral Capsule - alpha-1-adrenoblocker for treatment LUTS/BPH 0.4 mg; Routine transurethral prostatic resection
Other intervention name(s): Tamsulosin
Intervention MeSH terms: Tamsulosin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment