Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Benha University

Status: Not yet enrolling

Conditions: Benign Prostatic Hyperplasia; Tranexamic Acid; Transurethral Resection of the Prostate

Treatments: Drug: Tranexamic Acid group; Drug: Distilled water group

Study type: Interventional

Funder types: Other

Identifiers

NCT05913466

Rc 5-5-2022

Details and patient eligibility

About

This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.

Full description

Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.

The accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.

Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with an age between 50 and 85 years old
• who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.
• undergoing Transurethral resection of the prostate

Exclusion criteria

• Patient refusal.
• Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.
• Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.
• Patients with abnormal liver function test.
• Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Tranexamic Acid group

Experimental group

Description:

Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline

Treatment:

Drug: Tranexamic Acid group

Distilled water group

Placebo Comparator group

Description:

This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

Treatment:

Drug: Distilled water group