Treatment of Urethral Stricture With Urethral Drug Ball

Not Applicable

Recruiting

• Conditions: Urethral Stricture Less Than 2 cm
• Interventions: Procedure: Drug balloon dilatation; Procedure: Direct vision internal urethrotomy (DVIU)

• Registration Number: NCT05812482
• Lead Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

Brief Summary

To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-31
• Status Verified: 2022-08
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-02
• Last Update Submitted: 2023-04-02
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13
• Primary Completion: 2024-10-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Drug balloon dilatation	The test arm will be the treated by Drug Balloon
Control group	Direct vision internal urethrotomy (DVIU)	The control arm will be treated by Direct vision internal urethrotomy (DVIU)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Residual urine volume (PVR)	6 months post-procedure
Number of re-interventions after operation	1, 3, 6 months post-procedure
Maximum urinary flow rate (Qmax)	1 and 6 months post-procedure
Postoperative complications	1,3,6 months post-procedure	bleeding, false passage formation, rectal injury, infection, etc

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China