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

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

Study Overview

• Status: Recruiting
• Conditions: Urethral Stricture Less Than 2 cm
• Intervention / Treatment: Procedure: Drug balloon dilatation; Procedure: Direct vision internal urethrotomy (DVIU)

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Zhang; Phone Number: 010-80120666; Email: ting_zhang@lepumedical.com
• Study Contact Backup: Name: Jianye Wang; Phone Number: 13901058760; Email: wangjy@bjhmoh.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Hospital
      • Contact: Jianwei Wang; Phone Number: 13901058760; Email: wangjy@bjhmoh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
• Investigators: Study Director: Jianbing Li, Beijing Tsinghua Changgeng Hospital; Study Director: Jianbin Bi, First Hospital of China Medical University; Study Director: Qiang Fu, Shanghai 6th People's Hospital; Study Director: Shaogang Wang, Tongji Hospital Affiliated to Tongji Medical College Hust; Study Director: Xiaoping Zhang, Wuhan Union Hospital, China; Study Director: Yuanjie Niu, Tianjin Medical University Second Hospital; Study Director: Jinjian Yang, The First Affiliated Hospital of Zhengzhou University; Study Director: Weijun Qin, Air Force Medical University of PLA (the Fourth Military Medical University); Study Director: Lei Li, First Affiliated Hospital Xi'an Jiaotong University; Study Director: Deyi Luo, West China School of Medicine of Sichuan University; Study Director: Zhansong Zhou, Southwest Hospital, China; Study Director: Wei Yu, Peking University First Hospital; Study Director: Jianwei Wang, Beijing Jishuitan hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Estimate): April 13, 2023

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Urethral stricture
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: LPCTP-2021-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No