Treatment of Urethral Stricture With Urethral Drug Ball

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.

Detailed Description
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This is a prospective, multicenter, randomized controlled, and superiority study. The two groups were randomly selected into a total of 150 subjects (75 in the test group and 75 in the control group) according to 1:1. The test group was treated with urethral drug balloon catheter from Lepu Medical Technology (Beijing) Co.,Ltd., while the control group was treated with direct vision internal urethrotomy (DVIU). All subjects were followed up at 1, 3 and 6 months post-procedure, and the efficacy of urethral drug balloon catheter will be evaluated with the success rate of operation at 6 months as the main end point. Observe the occurrence of complications and other indicators to make a reliable evaluation of the safety of urethral drug balloon catheter.

Official Title
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A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Urethral Drug Balloon Catheter in the Treatment of Urethral Stricture

Conditions
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Urethral Stricture Less Than 2 cm

Intervention / Treatment
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* Procedure: Drug balloon dilatation
* Procedure: Direct vision internal urethrotomy (DVIU)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>The test arm will be the treated by Drug Balloon | Procedure: Drug balloon dilatation<br>* The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated<br>|
| Other: Control group<br>The control arm will be treated by Direct vision internal urethrotomy (DVIU) | Procedure: Direct vision internal urethrotomy (DVIU)<br>* A control subject will choose DVIU surgery until the desired effect is achieved<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | no reoperation or instrument intervention is required, and 16F bladder flexible mirror or 16F catheter can pass through the stenosis | 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the International Prostate Symptom Score (IPSS) |  | 1, 3 and 6months | 
| Change in the Quality of life index score (QOL) |  | 1, 3 and 6months | 
| Maximum urinary flow rate (Qmax) |  | 1 and 6 months post-procedure | 
| Residual urine volume (PVR) |  | 6 months post-procedure | 
| Postoperative complications | bleeding, false passage formation, rectal injury, infection, etc | 1,3,6 months post-procedure | 
| Number of re-interventions after operation |  | 1, 3, 6 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urethral stricture