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COMPLETED
NCT07883837
PHASE3

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-01

Completion Date

2026-04-01

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

PROCEDURE

Visual internal urethrotomy followed by submucosal intralesional mitomycin C 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 From this solution, 8 mL was withdrawn and further diluted with 2 mL of normal saline, resulting in a final volume of 10 mL at a concentration of 0.4 mg/mL, giving a total administered dose of 4 mg.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.

PROCEDURE

Visual internal urethrotomy followed by submucosal Platlet Rich Plasma injection

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.

Locations (1)

Faculty of Medicine, Ain Shams University, Demerdash hospitals.

Cairo, Abbassia, Egypt