Using Paclitaxel to Improve Treatment for Urethral Strictures
Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial
This study is testing if injecting a medication called paclitaxel after a specific urethra surgery can help people with urethral strictures avoid having the problem come back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05678413 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intralesional paclitaxel injection following direct visual internal urethrotomy (DVIU) for treating anterior urethral strictures. The study aims to reduce the high recurrence rates associated with DVIU by incorporating paclitaxel, which has shown promise in other interventions. Eligible participants will have short strictures and no prior treatments for stricture disease. The trial will assess outcomes based on symptom scores and flow rates post-procedure.
Who should consider this trial
Good fit: Ideal candidates are men with anterior urethral strictures less than 2 cm in length and no previous treatments.
Not a fit: Patients with recurrent strictures or those who have undergone prior pelvic radiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of urethral strictures and improve patient quality of life.
How similar studies have performed: While various intralesional injections have been tested in similar contexts, the specific use of paclitaxel in this manner is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Anterior urethral stricture * Short strictures (less than 2 cm) * International Prostate Symptom Score less than 11 and maximum flow rate \< 15 ml per second. * No previous treatment for stricture disease Exclusion Criteria: * Recurrent cases * Prior pelvic radiation * Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.
Where this trial is running
Cairo
- Mohamed Fawzy Salman — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed F Salman, MD
- Email: prof_mohamed_fawzy@yahoo.com
- Phone: +201111788996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.