Platelet Rich Plasma Versus Mitomycin C Injection Following Visual Internal Urethrotomy in Urethral Stricture

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• Men only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Platelet-Rich Plasma Versus Mitomycin C Injection Following Visual Internal Urethrotomy in the Management of Urethral Stricture in Adults: A Randomized Controlled Clinical Trial

Conditions

Urethral Stricture

Being tested

Visual internal urethrotomy followed by submucosal intralesional mitomycin C injection, Visual internal urethrotomy followed by submucosal Platlet Rich Plasma injection

Keywords

Urethral Stricture, Mitomycin C, Platlet Rich Plasma, Visual internal urethrotomy

Medical subject headings

Urethral Stricture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Visual internal urethrotomy followed by submucosal intralesional mitomycin C injectionProcedure or surgery

  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 From this solution, 8 mL was withdrawn and further diluted with 2 mL of normal saline, resulting in a final volume of 10 mL at a concentration of 0.4 mg/mL, giving a total administered dose of 4 mg.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.

• Visual internal urethrotomy followed by submucosal Platlet Rich Plasma injectionProcedure or surgery

  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 A total of 50 mL of whole blood was withdrawn with anticoagulant and centrifuged at 100 g for 15 minutes, then the platelet-containing plasma was collected and centrifuged again at 1600 g for 20 minutes at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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: At 3 months and 6 months after surgery

2. 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.

   Measured: At 3 months and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Oct 2026
2. Study start1 Aug 2025
3. Primary completion1 Mar 2026
4. Study completion1 Apr 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Urethral StrictureStudies of the same condition, open and under way.
• More trials run by Ain Shams UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.