A Propensity Score-Matched Protocol: Terazosin Plus Finasteride For Benign Prostatic Hyperplasia – Sex Hormone And Urinary Control Effects

Summary

The goal of this protocol is to evaluate, using a retrospective propensity score-matched cohort design, whether terazosin combined with finasteride improves long-term urinary control and sex hormone profiles compared with finasteride monotherapy in patients with benign prostatic hyperplasia.

Abstract

To investigate the clinical effect of terazosin hydrochloride combined with finasteride in benign prostatic hyperplasia (BPH), and to analyze its effect on sex hormones and urinary control. This retrospective propensity score‑matched (PSM) cohort study included BPH patients treated between January 2020 and March 2021. 1:1 PSM using logistic regression with prespecified covariates (age, BMI, IPSS, Qmax, PVR, PV, PSA, CRP, T, E2, DHT, incontinence episodes, ICIQ‑SF); inclusion criteria (age 50‑80 years, IPSS ≥ 8, PSA > 1.4 ng/mL, PV ≥ 40 mL, Qmax ≤ 15 mL/s); exclusion of prior prostate surgery or 5α‑reductase/α1‑blocker use; 12‑month treatment and 36 month follow up with outcomes measured at 6, 12, 24, 36 months. Sixty patients were allocated to each group after PSM. The combination group showed significantly greater improvements in IPSS, Qmax, PVR, and PV (all P < 0.05), lower DHT and E2, higher T (all P < 0.05), fewer 24 h incontinence episodes, and better ICIQ‑SF scores (both P < 0.05). Safety profiles were comparable (P > 0.05). The terazosin‑- finasteride regimen is associated with improved long-term outcomes, better urinary control, and favorable hormonal changes, though hormonal effects are primarily attributable to finasteride.

Introduction

Benign prostatic hyperplasia (BPH) is one of the most common urological diseases affecting middle-aged and elderly men. Its incidence increases with age. For example, the prevalence of BPH is about 50% in men aged 60 years and as high as 90% in those aged 81-90 years^1,2. As we age, the prostate increases in size and presses on the urethra, resulting in bladder outlet obstruction (BOO), thereby inducing lower urinary tract symptoms (LUTS), including urinary frequency, urgency, increased nocturia, dysuria, urinary retention, etc^3,4. Such symptoms markedl....

Protocol

This clinical study was conducted in compliance with the ethical principles outlined in the Declaration of Helsinki and was approved by the Ethics Committee of the Haiyan County People's Hospital(Approval No.: 2025-17).

Study participant assessment and selection

Clinical data were extracted for all patients diagnosed with BPH from the hospital's electronic medical record system, covering the period from January 2020 to March 2021.

PSM was employed using the 1:1 nearest-neighbor method to mitigate potential confounding factors and selection bias inherent in....

Results

The study initially enrolled 148 patients (76 in the combination group; 72 in the monotherapy group). To minimize potential confounding, 1:1 propensity score matching was applied, resulting in 120 successfully matched patients (60 per group). As presented in Table 1, significant baseline discrepancies (P < 0.05) existed before matching, with the monotherapy group being older and having higher C-reactive protein levels, total IPSS, voiding subscores, post-void residual urine, and nocturia episodes, suggesting .......

Discussion

The prostate is a gonadal organ located at the bladder neck, traversed centrally by the urethra. After age 45, age‑related changes in sex hormone metabolism are associated with prostatic growth, which may progress to BPH. The condition typically evolves slowly; patients may remain asymptomatic as long as there is no lower urinary tract obstruction. As prostate volume increases, or when complicated by stones or infection, urinary obstruction and voiding difficulties may develop, potentially compromising patient heal.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Automated Chemiluminescence Immunoassay Analyzer	F. Hoffmann-La Roche Ltd.	7682913001 (e 801 Module)	Used for quantitative detection of serum testosterone (T), estradiol (E2), and dihydrotestosterone (DHT).
Dihydrotestosterone (DHT) Detection Reagent Kit	Beijing Solarbio Science & Technology Co., Ltd.	SEKSM-0030	Used for quantitative detection of DHT concentration in serum and plasma.
Hospital Electronic Medical Record System	Winning Health Technology Group Co.,Ltd.	HIS V5.0	Used for retrospective extraction of patient data.
International Consultation on Incontinence Questionnaire-Short Form	—	ICI-Q-SF	Used to assess impact of urinary incontinence on quality of life.
International Prostate Symptom Score Questionnaire	—	IPSS (LOINC 80976-4)	Used to assess lower urinary tract symptoms (LUTS).
Laboratory Centrifuge	Thermo Fisher Scientific Inc.	75007201 (230V)	Used for serum separation. Standard conditions: 1500 × g for 10 minutes.
Sample Size Calculation Software	G*Power	Version 3.1	Used for a priori power analysis.
Sex Hormone Detection Reagent Kit	F. Hoffmann-La Roche Ltd.	Testosterone II: 05200067	Used for quantitative detection of testosterone or estradiol in serum/plasma on Roche analyzers.
Statistical Analysis Software	IBM SPSS Statistics	Version 25.0	Used for all data analysis.
Transrectal Ultrasound Diagnostic System	Koninklijke Philips N.V.	EPIQ 7 model 795200	Used to measure prostate volume (PV) and post-void residual (PVR).
Urinary Flowmeter	Guangzhou Pudong Medical Equipment Co., Ltd.	PT-UFM-A	Used to measure maximum urinary flow rate (Qmax).