A Phase 3 interventional study of Visual internal urethrotomy followed by submucosal intralesional mitomycin C injection and Visual internal urethrotomy followed by submucosal Platlet Rich Plasma injection in Urethral Stricture, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
this is a randomized clinical trial that was conducted at Ain Shams University to compare the effectiveness and safety of two different substances injected after visual internal urethrotomy for treating urethral stricture in adult men. Fifty male patients with short urethral strictures were randomly divided into two equal groups, with one group receiving a mitomycin C injection and the other receiving a platelet-rich plasma injection at the site of the urethrotomy. Patients were followed for six months, with evaluations at three and six months that included symptom scores, quality of life assessments, urine flow measurements, post-void residual urine volume, and recurrence rates.
70 studies on the registry are indexed under Urethral Stricture; 23 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 55 interventional studies indexed under Urethral Stricture.
Browse Urethral Stricture studies →Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients who underwent visual internal urethrotomy followed by submucosal intralesional mitomycin C injection.
Procedure: Visual internal urethrotomy followed by submucosal intralesional mitomycin C injection
Patients who underwent visual internal urethrotomy followed by submucosal intralesional platelet-rich plasma injection.
Procedure: Visual internal urethrotomy followed by submucosal Platlet Rich Plasma injection
Patients underwent visual internal urethrotomy using a cold knife at the 12 o'clock position, with additional incisions at the 4 and 8 o'clock positions if needed, until healthy tissue was reached. After the incision, a vial containing 10 mg of mitomycin C was reconstituted with 20 mL of normal saline to obtain a stock solution of 0.5 mg/mL. From this solution, 8 mL was withdrawn and further diluted with 2 mL of normal saline, resulting in a final volume of 10 mL at a concentration of 0.4 mg/mL, giving a total administered dose of 4 mg. Using an endoscopic injection needle, 2 to 3 mL of the prepared mitomycin C solution was injected submucosally per site at the 12, 4, and 8 o'clock positions, with 2 to 3 additional sites injected in some cases, all under direct endoscopic vision at the incised stricture segment. A 20-F silicone urethral catheter was then left in place for 10 days.
Patients underwent visual internal urethrotomy in the same manner as Group A. Platelet-rich plasma was prepared using the double-spin method. A total of 50 mL of whole blood was withdrawn with anticoagulant and centrifuged at 100 g for 15 minutes, then the platelet-containing plasma was collected and centrifuged again at 1600 g for 20 minutes at 22°C. The lower third containing the platelet pellets was collected, yielding about 5 mL of sterile platelet-rich plasma, which was mixed with 5 mL of normal saline to produce a 10 mL solution. Using an endoscopic injection needle, 2 to 3 mL of the prepared platelet-rich plasma solution was injected submucosally per site at the 12, 4, and 8 o'clock positions, with additional sites injected in some cases, all under direct endoscopic vision. A 20-F silicone urethral catheter was then left in place for 10 days.
Clinical effectiveness in improving patient-reported lower urinary tract symptoms according to the International Prostate Symptom Score
This outcome measure assessed the degree of improvement in lower urinary tract symptoms reported by patients after the intervention. The International Prostate Symptom Score is a validated, patient-reported questionnaire consisting of seven questions that evaluate the severity of urinary symptoms, including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is scored from 0 to 5, giving a total score range of 0 to 35, where scores of 1 to 7 indicate mild symptoms, 8 to 19 indicate moderate symptoms, and 20 to 35 indicate severe symptoms.
Time frame: At 3 months and 6 months after surgery
Clinical effectiveness in improving patient's uroflometry
This outcome assessed urinary flow using uroflowmetry, a non-invasive test measuring the rate and pattern of urine flow.It records average and maximum urinary flow rates in milliliters per second. These values were compared between both groups to determine whether either treatment produced greater improvement. A maximum flow rate above 10 mL per second was considered successful, while a value below 10 mL per second was considered suspicious for recurrence and prompted further evaluation with retrograde cystourethrography.
Time frame: At 3 months and 6 months after surgery
Quality of Life Assessment
This outcome assessed the impact of urinary symptoms on patients' daily lives using the quality of life question from the International Prostate Symptom Score questionnaire. Patients were asked how they would feel if they had to spend the rest of their lives with their current urinary condition, with responses ranging from delighted to terrible on a scale of 0 to 6.
Time frame: At 3 months and 6 months after surgery
Post-void residual urine volume
This outcome assessed bladder emptying by measuring the amount of urine remaining in the bladder after voiding, using pelvi-abdominal ultrasound.
Time frame: At 3 months and 6 months after surgery
Plan to share: No
Ran from Aug 2025 to primary completion in Mar 2026, 7 months.
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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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