Clinical trial to evaluate the efficacy of probiotics as an adjunctive treatment in the management of benign prostatic hyperplasia (BPH) in patients attending the urology clinic of Imam Reza Hospital

Improvement of the quality of life of patients with benign prostatic hyperplasia through low-risk and effective probiotic-based treatments

The present study is conducted as a randomized, double‑blind, phase III clinical trial with parallel groups on 88 patients. Permuted block randomization is used for randomization.

This study is conducted as a double-blind clinical trial on patients with benign prostatic hyperplasia attending the urology clinic of Imam Reza Hospital in Tehran. Informed consent is obtained from the participants, and they are then randomly assigned to one of the study groups. In the intervention group, patients receive Tamsulosin 0.4 mg once daily and Gerilact probiotic twice daily (morning and night) for 12 weeks. Patients in the control group receive only Tamsulosin 0.4 mg once daily. Both the patients and the data evaluator are blinded to group allocation.

The inclusion criteria for the study include a definitive diagnosis of benign prostatic hyperplasia based on clinical symptoms and ultrasound confirmation, and consent to participate in the study. The exclusion criteria include chronic diseases such as prostate cancer and the use of anti-inflammatory drugs before the start of the study.

Patients in the intervention group receive Tamsulosin 0.4 mg once daily and Gerliact probiotic tablets twice daily (morning and night) for 12 weeks. In the control group, patients only take Tamsulosin 0.4 mg once daily.

International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post‑void residual urine volume (PVR), prostate‑specific antigen (PSA).

The method used is permuted block randomization. For this purpose, two treatment groups, A and B, are defined in blocks as AB and BA. Then, numbers from a random table in the range 0 to 9 are considered. Numbers 0 to 4 are assigned to block AB, and numbers 5 to 9 are assigned to block BA. Random numbers are then selected from the table. If the number 0 appears, it corresponds to block AB, and therefore two individuals enter this block, such that the first individual receives treatment A and the second individual receives treatment B. In the same way, the treatment groups for the remaining participants are determined. Although in this method the number of observations in both groups will be equal, because of the small block sizes, there is a high probability that the person conducting the study may predict the treatment group assignment. To solve this problem, the randomization list is prepared before the start of the study by a blinded individual who is not part of the treatment team. Additionally, the block sizes will be increased.

Unwillingness to participate in the research project. This study is conducted in a double-blind manner; such that patients will be unaware of the type of intervention or their assigned group, and the assessor will also remain unaware of the patients’ allocation to study groups. In order to maintain blinding, the intervention in both groups is designed to be as similar as possible in terms of appearance, method of presentation, and implementation conditions, and the interventions are recorded with specific codes, and the information related to the codes is kept by an individual outside the assessment process until the end of data collection and analysis.