LishitonglinUS-01 Trial

Efficacy and Safety Evaluation of Lishitonglin Formula in Improving Preoperative Non-Severe Urinary Tract Infections and Lower Urinary Tract Symptoms in Patients With Urethral Stricture

This study intends to conduct a prospective, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Lishi Tonglin Granule (a hospital-formulated innovative prescription) developed in our hospital for alleviating preoperative urinary tract infections in patients with urethral stricture, and to further explore its effects on preoperative lower urinary tract irritation symptoms as well as short- and medium-term postoperative stricture recurrence rates.

This protocol is jointly implemented by the Department of Urology and the Department of Integrated Traditional Chinese and Western Medicine. Adopting the TCM therapeutic concept of "clearing the source and unblocking collaterals" combined with Western surgical intervention, the trial compares the primary outcome measures between the intervention group (administered Lishi Tonglin Prescription) and the control group (administered placebo), including preoperative bacteriuria clearance rate, lower urinary tract symptom scores and TCM syndrome scores, to identify significant intergroup differences.

Comprehensive analyses will also be performed on postoperative short- and medium-term urination improvement, urethral stricture recurrence risk, distribution of uropathogens and antimicrobial susceptibility profiles of the two groups. This research features innovations in integrated Chinese-Western diagnostic and therapeutic theories, prescription optimization, and a multi-dimensional evaluation framework. Its findings can validate the clinical potential of Lishi Tonglin Prescription as an alternative to antibiotics, and lay a theoretical foundation for future mechanistic research and clinical translation of integrated Chinese-Western therapy for urinary tract infections secondary to lower urinary tract obstruction.

Inclusion Criteria:

• 1. Adult male patients (≥18 years old) with urethral stricture diagnosed by urethrography and presenting urinary obstruction symptoms (AUA grade II-III) with or without preoperative bladder diversion via ostomy.
• 2. No concurrent severe urinary tract infection (meeting both criteria): · Urinary tract irritation symptoms (frequency, urgency, dysuria)
• 3. Urinary leukocytes ≥10 (HPF)
• 4. Midstream urine culture colony count ≥10⁵ CFU/mL
• 5. Traditional Chinese Medicine pattern identification: damp-heat descending syndrome (primary symptoms: frequent, urgent, painful urination, red tongue with thick yellow coating)
• 6. Planned intraurethral procedures (including urethrotomy/urethral dilation/urethral balloon dilation) or open urethroplasty (including end-to-end urethral stricture resection/autologous mucosal patch urethroplasty).

Exclusion Criteria:

• 1. Patients with severe infection presenting clinically significant symptoms at enrollment: e.g., those with fever, active hematuria, pyuria, urethral condyloma, or septic shock
• 2. Urinary tract infections complicated by complex urinary tract anomalies (e.g., congenital hypospadias, fistula) or uncontrolled malignant tumors such as urethral cancer or bladder cancer
• 3. Severe hepatic or renal dysfunction (ALT/AST > 2× upper limit of normal, Scr > 133 μmol/L)
• 4. Concurrent immunodeficiency disorders or use of immunosuppressive agents
• 5. Allergy to any component of the study drug
• 6. Individuals refusing to participate in this study.