NCT05812482

Treatment of Urethral Stricture With Urethral Drug Ball

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urethral Stricture Less Than 2 cm

Interventions

Type	Name	Description
PROCEDURE	Drug balloon dilatation	The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated
PROCEDURE	Direct vision internal urethrotomy (DVIU)	A control subject will choose DVIU surgery until the desired effect is achieved

Timeline

• Start date: 2022-03-31
• Primary completion: 2024-10-31
• Completion: 2025-02-28
• First posted: 2023-04-13
• Last updated: 2023-04-13

Locations

1 site across 1 country: China