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Treatment of Urethral Stricture With Urethral Drug Ball

Primary Purpose

Urethral Stricture Less Than 2 cm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug balloon dilatation
Direct vision internal urethrotomy (DVIU)
Sponsored by
Lepu Medical Technology (Beijing) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture Less Than 2 cm focused on measuring Urethral stricture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test group

Control group

Arm Description

The test arm will be the treated by Drug Balloon

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

Outcomes

Primary Outcome Measures

Procedural success
no reoperation or instrument intervention is required, and 16F bladder flexible mirror or 16F catheter can pass through the stenosis

Secondary Outcome Measures

Change in the International Prostate Symptom Score (IPSS)
Change in the Quality of life index score (QOL)
Maximum urinary flow rate (Qmax)
Residual urine volume (PVR)
Postoperative complications
bleeding, false passage formation, rectal injury, infection, etc
Number of re-interventions after operation

Full Information

First Posted
March 15, 2023
Last Updated
April 2, 2023
Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05812482
Brief Title
Treatment of Urethral Stricture With Urethral Drug Ball
Official Title
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Urethral Drug Balloon Catheter in the Treatment of Urethral Stricture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture Less Than 2 cm
Keywords
Urethral stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
The test arm will be the treated by Drug Balloon
Arm Title
Control group
Arm Type
Other
Arm Description
The control arm will be treated by Direct vision internal urethrotomy (DVIU)
Intervention Type
Procedure
Intervention Name(s)
Drug balloon dilatation
Intervention Description
The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated
Intervention Type
Procedure
Intervention Name(s)
Direct vision internal urethrotomy (DVIU)
Intervention Description
A control subject will choose DVIU surgery until the desired effect is achieved
Primary Outcome Measure Information:
Title
Procedural success
Description
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
Secondary Outcome Measure Information:
Title
Change in the International Prostate Symptom Score (IPSS)
Time Frame
1, 3 and 6months
Title
Change in the Quality of life index score (QOL)
Time Frame
1, 3 and 6months
Title
Maximum urinary flow rate (Qmax)
Time Frame
1 and 6 months post-procedure
Title
Residual urine volume (PVR)
Time Frame
6 months post-procedure
Title
Postoperative complications
Description
bleeding, false passage formation, rectal injury, infection, etc
Time Frame
1,3,6 months post-procedure
Title
Number of re-interventions after operation
Time Frame
1, 3, 6 months post-procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Zhang
Phone
010-80120666
Email
ting_zhang@lepumedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianye Wang
Phone
13901058760
Email
wangjy@bjhmoh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianbing Li
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jianbin Bi
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qiang Fu
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaogang Wang
Organizational Affiliation
Tongji Hospital affiliated to Tongji Medical College HUST
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiaoping Zhang
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuanjie Niu
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jinjian Yang
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Weijun Qin
Organizational Affiliation
Air Force Medical University of PLA (the Fourth Military Medical University)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Li
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deyi Luo
Organizational Affiliation
West China School of Medicine of Sichuan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhansong Zhou
Organizational Affiliation
Southwest Hospital, China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wei Yu
Organizational Affiliation
Peking University First Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jianwei Wang
Organizational Affiliation
Beijing Jishuitan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Wang
Phone
13901058760
Email
wangjy@bjhmoh.cn

12. IPD Sharing Statement

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Treatment of Urethral Stricture With Urethral Drug Ball

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