Treatment of Urethral Stricture With Urethral Drug Ball (NCT05812482) | Clinical Trial Compass
UnknownNot Applicable
Treatment of Urethral Stricture With Urethral Drug Ball
China150 participantsStarted 2022-03-31
Plain-language summary
To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.
Who can participate
Age range18 Years – 85 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Procedural success
Timeframe: 6 months post-procedure
Trial details
NCT IDNCT05812482
SponsorLepu Medical Technology (Beijing) Co., Ltd.