Last updated: April 2, 2023
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Enuresis
Peyronie's Disease
Treatment
N/AClinical Study ID
NCT05812482
LPCTP-2021-009
Ages 18-85 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 and ≤ 85 years old, male patients;
- Urethral stricture was confirmed by transurethral angiography, and the length ofstricture 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 inand sign the informed consent form, can independently complete effectivequestionnaires, and are willing to conduct clinical follow-up according to theresearch requirements.
Exclusion
Exclusion Criteria:
- Patients with multiple stenotic lesions;
- Patients with a history of allergy to paclitaxel and contrast agents, or patientsundergoing treatment with drugs that may antagonize paclitaxel;
- Patients who have undergone hypospadias repair, urethroplasty, stricture expansionor incision in the past 3 months;
- Urethral stricture caused by the following causes: bacterial urethritis, untreatedgonorrhea, lichen sclerosus or dry glans obliterans;
- There are other diseases that can cause lower urinary tract symptoms, such asoveractivity of bladder, neurogenic bladder dysfunction, etc;
- There are adverse factors for catheter insertion;
- Patients with artificial penis or urethral sphincter, or urethral or prostatestent;
- Patients who have been diagnosed with urethra cancer, bladder cancer cancer orprostate 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 dysfunctionand contraindication of anesthesia;
- Patients with poor control of diabetes (hemoglobin A1c>8.0%);
- Patients with active urinary stones in the past 6 months;
- Patients who are not suitable for direct vision internal urethrotomy;
- Patients with pregnancy preparation plan;
- Patients who are participating in clinical trials of other drugs or medicaldevices and have not reached their main endpoint;
- Patients who cannot participate in the clinical trial due to other reasonsconsidered by the investigator.
Study Design
Total Participants: 150
Study Start date:
March 31, 2022
Estimated Completion Date:
February 28, 2025
Study Description
Connect with a study center
Beijing Hospital
Beijing, Beijing 100005
ChinaActive - Recruiting
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