Clinical trial NCT05812482: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urethral Stricture Less Than 2 cm
Keywords: Urethral stricture
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Procedural success
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Change in the International Prostate Symptom Score (IPSS)
timeFrame: 1, 3 and 6months
measure: Change in the Quality of life index score (QOL)
timeFrame: 1, 3 and 6months
measure: Maximum urinary flow rate (Qmax)
timeFrame: 1 and 6 months post-procedure
measure: Residual urine volume (PVR)
timeFrame: 6 months post-procedure
measure: Postoperative complications
timeFrame: 1,3,6 months post-procedure
measure: Number of re-interventions after operation
timeFrame: 1, 3, 6 months post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Jianbing Li
role: STUDY_DIRECTOR
affiliation: First Hospital of China Medical University
name: Jianbin Bi
role: STUDY_DIRECTOR
affiliation: Shanghai 6th People's Hospital
name: Qiang Fu
role: STUDY_DIRECTOR
affiliation: Tongji Hospital affiliated to Tongji Medical College HUST
name: Shaogang Wang
role: STUDY_DIRECTOR
affiliation: Wuhan Union Hospital, China
name: Xiaoping Zhang
role: STUDY_DIRECTOR
affiliation: Tianjin Medical University Second Hospital
name: Yuanjie Niu
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Jinjian Yang
role: STUDY_DIRECTOR
affiliation: Air Force Medical University of PLA (the Fourth Military Medical University)
name: Weijun Qin
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Lei Li
role: STUDY_DIRECTOR
affiliation: West China School of Medicine of Sichuan University
name: Deyi Luo
role: STUDY_DIRECTOR
affiliation: Southwest Hospital, China
name: Zhansong Zhou
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Wei Yu
role: STUDY_DIRECTOR
affiliation: Beijing Jishuitan Hospital
name: Jianwei Wang
role: STUDY_DIRECTOR
References: