Treatment of Urethral Stricture With Urethral Drug Ball

NCT ID: NCT05812482

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2025-02-28

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.

Conditions

Urethral Stricture Less Than 2 cm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

The test arm will be the treated by Drug Balloon

Group Type: EXPERIMENTAL

Drug balloon dilatation

Intervention Type: PROCEDURE

The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated

Control group

The control arm will be treated by Direct vision internal urethrotomy (DVIU)

Group Type: OTHER

Direct vision internal urethrotomy (DVIU)

Intervention Type: PROCEDURE

A control subject will choose DVIU surgery until the desired effect is achieved

Interventions

Drug balloon dilatation

The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated

Intervention Type: PROCEDURE

Direct vision internal urethrotomy (DVIU)

A control subject will choose DVIU surgery until the desired effect is achieved

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianbing Li

Role: STUDY_DIRECTOR

Beijing Tsinghua Changgeng Hospital

Jianbin Bi

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Qiang Fu

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Shaogang Wang

Role: STUDY_DIRECTOR

Tongji Hospital affiliated to Tongji Medical College HUST

Xiaoping Zhang

Role: STUDY_DIRECTOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Yuanjie Niu

Role: STUDY_DIRECTOR

Tianjin Medical University Second Hospital

Jinjian Yang

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhengzhou University

Weijun Qin

Role: STUDY_DIRECTOR

Air Force Medical University of PLA (the Fourth Military Medical University)

Lei Li

Role: STUDY_DIRECTOR

First Affiliated Hospital Xi'an Jiaotong University

Deyi Luo

Role: STUDY_DIRECTOR

West China School of Medicine of Sichuan University

Zhansong Zhou

Role: STUDY_DIRECTOR

Southwest Hospital, China

Wei Yu

Role: STUDY_DIRECTOR

Peking University First Hospital

Jianwei Wang

Role: STUDY_DIRECTOR

Beijing Jishuitan Hospital

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Zhang

Role: CONTACT

ting_zhang@lepumedical.com

010-80120666

Jianye Wang

Role: CONTACT

wangjy@bjhmoh.cn

13901058760

Facility Contacts

Jianwei Wang

Role: primary

wangjy@bjhmoh.cn

13901058760

Other Identifiers

LPCTP-2021-009

Identifier Type: -

Identifier Source: org_study_id