To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated
A control subject will choose DVIU surgery until the desired effect is achieved
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGProcedural success
no reoperation or instrument intervention is required, and 16F bladder flexible mirror or 16F catheter can pass through the stenosis
Time frame: 6 months post-procedure
Change in the International Prostate Symptom Score (IPSS)
Time frame: 1, 3 and 6months
Change in the Quality of life index score (QOL)
Time frame: 1, 3 and 6months
Maximum urinary flow rate (Qmax)
Time frame: 1 and 6 months post-procedure
Residual urine volume (PVR)
Time frame: 6 months post-procedure
Postoperative complications
bleeding, false passage formation, rectal injury, infection, etc
Time frame: 1,3,6 months post-procedure
Number of re-interventions after operation
Time frame: 1, 3, 6 months post-procedure
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