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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bacterial clearance rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
This study will establish two groups: a trial group (Lishitonglin Formula trial group) and a control group (placebo). Prior to enrollment, patients will undergo stratified randomization based on the severity of their urethral stricture and the planned surgical procedure. Randomized numbering will follow this stratification. Considering the actual patient distribution in clinical practice, the first and second strata will be stratified and randomized in an approximate 3:2 sample ratio.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Trial Group - Mild Stenosis Group
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
干预措施: Lishitonglin Formula granules (Drug)
Trial Group - Moderate to Severe Stenosis Group
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
干预措施: Lishitonglin Formula granules (Drug)
Control Group - Mild Stenosis Group
One week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water).
干预措施: Oral placebo medication formulated as granules (Drug)
Control Group - Moderate to Severe Stenosis Group
One week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water).
干预措施: Oral placebo medication formulated as granules (Drug)
结局指标
主要结局
Bacterial clearance rate
时间窗: Before taking the drug and one day before operation
After 7 days of treatment, the rate of reduction in urinary leukocyte count under high-power microscopy compared to pre-treatment levels, urinary leukocyte count (high-power microscopy), and urinary culture conversion rate
次要结局
- Urine White Blood Cell Count on the First Day After Surgery(Postoperative Day 1)
- Traditional Chinese Medicine Syndrome Scoring(Before taking the drug and one day before operation)
- Recurrence rate(Postoperative 3 months & 1 year)
- Drug related adverse effects(Through study completion, on average of 1 week)
- Urine Culture Positivity Rates and Microorganism Types(Before taking the drug and one day before operation)
- International Prostate Symptom Score (IPSS)(Before taking the drug and one day before operation)
研究者
Chunru Xu
Dr.
Peking University First Hospital