Urethra Stricture
Conditions
Keywords
Urethra stricture, Lishitonglin Formula, Perioperational urinary infection, RCT
Brief summary
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.
Detailed description
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.
Interventions
DRUGLishitonglin Formula granules
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
DRUGOral placebo medication formulated as granules
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).
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Prospective, randomized, double-blind, control study
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial clearance rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | Before taking the drug and one day before operation | This scale includes seven symptoms: frequent urination, urinary urgency, nocturia, incomplete emptying, interrupted urination, difficulty urinating, and a weak urine stream. Each symptom is scored on a scale of 0-5 based on frequency and severity. The total score is categorized as follows: (0-7) mild, (8-19) moderate, and (20-35) severe. |
| Drug related adverse effects | Through study completion, on average of 1 week | Drug related adverse effects detected by real-time observation, inquiry, and recording |
| Urine Culture Positivity Rates and Microorganism Types | Before taking the drug and one day before operation | This refers to the proportion of patients with positive preoperative urine cultures, and includes documentation of the microbial species and antibiotic resistance profiles of the positive cultures. |
| Urine White Blood Cell Count on the First Day After Surgery | Postoperative Day 1 | Urine White Blood Cell Count Under High-Power Microscope in a Routine Urinalysis (Unit: cells/HP) |
| Traditional Chinese Medicine Syndrome Scoring | Before taking the drug and one day before operation | Urinating stenosis, frequent urination, urgency, and painful urination (4 items; scored on a 0-3 scale, with each item scored separately; 0 being the mildest and 3 the most severe) |
| Recurrence rate | Postoperative 3 months & 1 year | US Recurrence rate, followed by Urethrography, uroflowmetry, urethroscopy, and IPSS score |
Countries
China
Outcome results
None listed