Urethral Stricture Less Than 2 cmNCT05812482
Treatment of Urethral Stricture With Urethral Drug Ball
A study testing Drug balloon dilatation and Direct vision internal urethrotomy (DVIU) in people with Urethral Stricture Less Than 2 cm, run by Lepu Medical Technology (Beijing) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Urethral Stricture Less Than 2 cm
- What is being tested?
- Drug balloon dilatation and Direct vision internal urethrotomy (DVIU)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Jianwei Wang, 13901058760, wangjy@bjhmoh.cn
About this study
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
To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.
Read the 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
- Being tested
- Drug balloon dilatation, Direct vision internal urethrotomy (DVIU)
- Keywords
- Urethral stricture
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug balloon dilatationProcedure or surgery
The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated
Direct vision internal urethrotomy (DVIU)Procedure or surgery
A control subject will choose DVIU surgery until the desired effect is achieved
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The test arm will be the treated by Drug Balloon Receives: Procedure: Drug balloon dilatation |
| Control group | Other | The control arm will be treated by Direct vision internal urethrotomy (DVIU) Receives: Procedure: Direct vision internal urethrotomy (DVIU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
no reoperation or instrument intervention is required, and 16F bladder flexible mirror or 16F catheter can pass through the stenosis
Measured: 6 months post-procedure
Secondary outcomes (6)
Change in the International Prostate Symptom Score (IPSS)
Measured: 1, 3 and 6months
Change in the Quality of life index score (QOL)
Measured: 1, 3 and 6months
Maximum urinary flow rate (Qmax)
Measured: 1 and 6 months post-procedure
Residual urine volume (PVR)
Measured: 6 months post-procedure
Postoperative complications
bleeding, false passage formation, rectal injury, infection, etc
Measured: 1,3,6 months post-procedure
Number of re-interventions after operation
Measured: 1, 3, 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start31 Mar 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Stricture Less Than 2 cmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianbing Li, Study director, Beijing Tsinghua Changgeng HospitalJianbin Bi, Study director, First Hospital of China Medical UniversityQiang Fu, Study director, Shanghai 6th People's HospitalShaogang Wang, Study director, Tongji Hospital affiliated to Tongji Medical College HUSTXiaoping Zhang, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyYuanjie Niu, Study director, Tianjin Medical University Second HospitalJinjian Yang, Study director, The First Affiliated Hospital of Zhengzhou UniversityWeijun Qin, Study director, Air Force Medical University of PLA (the Fourth Military Medical University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812482
- Sponsor's protocol ID
- LPCTP-2021-009
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05812482
- Acronym / sponsor ID
- LPCTP-2021-009
- Conditions
- Urethral Stricture Less Than 2 cm
- Keywords
- Urethral stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Drug balloon dilatationThe test arm will be the treated by Drug Balloon |
| Control group | Other | Procedure: Direct vision internal urethrotomy (DVIU)The control arm will be treated by Direct vision internal urethrotomy (DVIU) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug balloon dilatationThe Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated | Procedure or surgery | Test group |
| Direct vision internal urethrotomy (DVIU)A control subject will choose DVIU surgery until the desired effect is achieved | Procedure or surgery | Control group |
Primary outcome
Procedural success
Time frame: 6 months post-procedure
no reoperation or instrument intervention is required, and 16F bladder flexible mirror or 16F catheter can pass through the stenosis
6 secondary outcomes
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
Time frame: 1,3,6 months post-procedure
Number of re-interventions after operation
Time frame: 1, 3, 6 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Related trials for Urethral Stricture Less Than 2 cm
Not yet recruiting
Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Urethral Stricture, Urethral Stricture, Anterior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianbing Li study director
Beijing Tsinghua Changgeng Hospital
Jianbin Bi study director
First Hospital of China Medical University
Qiang Fu study director
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug balloon dilatation and Direct vision internal urethrotomy (DVIU) in people with Urethral Stricture Less Than 2 cm, run by Lepu Medical Technology (Beijing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhang (010-80120666, ting_zhang@lepumedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.