Treatment of Urethral Stricture With Urethral Drug Ball

NCT05812482 | Unknown

• 1 other identifier: LPCTP-2021-009
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.

Conditions

Urethral Stricture Less Than 2 cm

Keywords

Urethral stricture

Outcome Measures

Primary Outcomes (1)

• Procedural success

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

  6 months post-procedure

Secondary Outcomes (6)

• Change in the International Prostate Symptom Score (IPSS)

  1, 3 and 6months

• Change in the Quality of life index score (QOL)

  1, 3 and 6months

• Maximum urinary flow rate (Qmax)

  1 and 6 months post-procedure

• Residual urine volume (PVR)

  6 months post-procedure

• Postoperative complications

  1,3,6 months post-procedure

Study Arms (2)

Test group

EXPERIMENTAL

The test arm will be the treated by Drug Balloon

Procedure: Drug balloon dilatation

Control group

OTHER

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

Procedure: Direct vision internal urethrotomy (DVIU)

Interventions

Drug balloon dilatation PROCEDURE

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

Test group

Direct vision internal urethrotomy (DVIU) PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 and ≤ 85 years old, male patients;
• \. Urethral stricture was confirmed by transurethral angiography, and the length of stricture 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 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.

You may not qualify if:

• \. Patients with multiple stenotic lesions;
• \. Patients with a history of allergy to paclitaxel and contrast agents, or patients undergoing treatment with drugs that may antagonize paclitaxel;
• \. Patients who have undergone hypospadias repair, urethroplasty, stricture expansion or incision in the past 3 months;
• \. Urethral stricture caused by the following causes: bacterial urethritis, untreated gonorrhea, lichen sclerosus or dry glans obliterans;
• \. There are other diseases that can cause lower urinary tract symptoms, such as overactivity of bladder, neurogenic bladder dysfunction, etc;
• \. There are adverse factors for catheter insertion;
• \. Patients with artificial penis or urethral sphincter, or urethral or prostate stent;
• \. 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;
• \. 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 dysfunction and 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 medical devices and have not reached their main endpoint;

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jianbing Li

  Beijing Tsinghua Changgeng Hospital

  STUDY DIRECTOR

• Jianbin Bi

  First Hospital of China Medical University

  STUDY DIRECTOR

• Qiang Fu

  Shanghai 6th People's Hospital

  STUDY DIRECTOR

• Shaogang Wang

  Tongji Hospital affiliated to Tongji Medical College HUST

  STUDY DIRECTOR

• Xiaoping Zhang

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

  STUDY DIRECTOR

• Yuanjie Niu

  Tianjin Medical University Second Hospital

  STUDY DIRECTOR

• Jinjian Yang

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

• Weijun Qin

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

  STUDY DIRECTOR

• Lei Li

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

• Deyi Luo

  West China School of Medicine of Sichuan University

  STUDY DIRECTOR

• Zhansong Zhou

  Southwest Hospital, China

  STUDY DIRECTOR

• Wei Yu

  Peking University First Hospital

  STUDY DIRECTOR

• Jianwei Wang

  Beijing Jishuitan Hospital

  STUDY DIRECTOR

Central Study Contacts

Ting Zhang

CONTACT

010-80120666; ting_zhang@lepumedical.com

Jianye Wang

CONTACT

13901058760; wangjy@bjhmoh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 13, 2023
• Study Start: March 31, 2022
• Primary Completion: October 31, 2024
• Study Completion: February 28, 2025
• Last Updated: April 13, 2023

Record last verified: 2022-08

Locations

CN (1)