Treatment of Urethral Stricture With Urethral Drug Ball
Urethral Stricture Less Than 2 cm
About this trial
This is an interventional treatment trial for Urethral Stricture Less Than 2 cm focused on measuring Urethral stricture
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 and ≤ 85 years old, male patients; 2. Urethral stricture was confirmed by transurethral angiography, and the length of stricture was less than 2 cm; 3. Maximum urine flow rate (Qmax)<15 ml/s; 4. There are obvious symptoms of urinary tract stricture such as slow urine rheology, difficulty in urination and incomplete urination; 5. International Prostate Symptom Score (IPSS) ≥ 13; 6. The guide wire must be able to pass through the stenosis segment; 7. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, can independently complete effective questionnaires, and are willing to conduct clinical follow-up according to the research requirements. Exclusion Criteria: 1. Patients with multiple stenotic lesions; 2. Patients with a history of allergy to paclitaxel and contrast agents, or patients undergoing treatment with drugs that may antagonize paclitaxel; 3. Patients who have undergone hypospadias repair, urethroplasty, stricture expansion or incision in the past 3 months; 4. Urethral stricture caused by the following causes: bacterial urethritis, untreated gonorrhea, lichen sclerosus or dry glans obliterans; 5. There are other diseases that can cause lower urinary tract symptoms, such as overactivity of bladder, neurogenic bladder dysfunction, etc; 6. There are adverse factors for catheter insertion; 7. Patients with artificial penis or urethral sphincter, or urethral or prostate stent; 8. Patients who have been diagnosed with urethra cancer, bladder cancer cancer or prostate cancer, or who have experienced pelvic radiotherapy in the past 2 years; 9. For patients with severe renal insufficiency, their serum creatinine is more than 2.5mg/dL or they are undergoing hemodialysis; 10. Patients with severe lung disease, cardiovascular disease, coagulation dysfunction and contraindication of anesthesia; 11. Patients with poor control of diabetes (hemoglobin A1c>8.0%); 12. Patients with active urinary stones in the past 6 months; 13. Patients who are not suitable for direct vision internal urethrotomy; 14. Patients with pregnancy preparation plan; 15. Patients who are participating in clinical trials of other drugs or medical devices and have not reached their main endpoint; 16. Patients who cannot participate in the clinical trial due to other reasons considered by the investigator.
Sites / Locations
- Beijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Test group
Control group
The test arm will be the treated by Drug Balloon
The control arm will be treated by Direct vision internal urethrotomy (DVIU)