Benign Prostatic Hyperplasia and Ischemic Heart DIsease

NCT03856242 | Completed Phase 4

• 1 other identifier: 03-19
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischaemic Heart Disease (IHD); Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  up to 6 months

Study Arms (3)

No intervention

NO INTERVENTION

It included the patients in whom during urination certain changes in HM were registered. The Group 1 patients' age varied from 63 to 79 years (mean 68.6±4.94 years). Nearly all except two patients (cardiac background of these patients did not require medical or surgical correction) from this group received cardiotropic therapy which did not change during one-month follow-up.

Tamsulosin

ACTIVE COMPARATOR

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.

Drug: Tamsulosin Oral Capsule

TURP

ACTIVE COMPARATOR

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).

Procedure: TURP

Interventions

Tamsulosin Oral Capsule DRUG

Tamsulosin Oral Capsule - alpha-1-adrenoblocker for treatment LUTS/BPH 0.4 mg

Also known as: Tamsulosin

Tamsulosin

TURP PROCEDURE

Routine transurethral prostatic resection

TURP

Eligibility Criteria

• Age: 57 Years - 81 Years
• Gender Eligibility Details: Benign prostatic hyperplasia - is a disease diagnosed only in males older than 50 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Related Publications (1)

• Fiev DN, Vinarov AZ, Tsarichenko DG, Kopylov PY, Demidko YL, Syrkin AL, Rapoport LM, Alyaev YG, Glybochko PV. Holter Monitoring (24-Hour ECG) Parameter Dynamics in Patients with Ischemic Heart Disease and Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Adv Ther. 2019 Aug;36(8):2072-2085. doi: 10.1007/s12325-019-00977-8. Epub 2019 May 30.

  PMID: 31148056 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Tamsulosin; Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Andrey Z Vinarov, PhD

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 27, 2019
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02