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

Lepu Medical Technology (Beijing) Co., Ltd.1 site in 1 country150 target enrollmentMarch 31, 2022

ConditionsUrethral Stricture Less Than 2 cm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urethral Stricture Less Than 2 cm
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: Procedural success
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 31, 2022

End Date

February 28, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 and ≤ 85 years old, male patients;
•Urethral stricture was confirmed by transurethral angiography, and the length of stricture was less than 2 cm;
•Maximum urine flow rate (Qmax)\<15 ml/s;
•There are obvious symptoms of urinary tract stricture such as slow urine rheology, difficulty in urination and incomplete urination;
•International Prostate Symptom Score (IPSS) ≥ 13;
•The guide wire must be able to pass through the stenosis segment;
•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

•Patients with multiple stenotic lesions;
•Patients with a history of allergy to paclitaxel and contrast agents, or patients undergoing treatment with drugs that may antagonize paclitaxel;
•Patients who have undergone hypospadias repair, urethroplasty, stricture expansion or incision in the past 3 months;
•Urethral stricture caused by the following causes: bacterial urethritis, untreated gonorrhea, lichen sclerosus or dry glans obliterans;
•There are other diseases that can cause lower urinary tract symptoms, such as overactivity of bladder, neurogenic bladder dysfunction, etc;
•There are adverse factors for catheter insertion;
•Patients with artificial penis or urethral sphincter, or urethral or prostate stent;
•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;
•For patients with severe renal insufficiency, their serum creatinine is more than 2.5mg/dL or they are undergoing hemodialysis;
•Patients with severe lung disease, cardiovascular disease, coagulation dysfunction and contraindication of anesthesia;