Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

October 1, 2023

Study Completion Date

October 15, 2023

Conditions
Urethral Stricture, Male
Interventions
PROCEDURE

Ho-YAG Laser Visual internal urethrotomy

"the operations will be performed by an expert surgeon and operative time will be considered. The procedure will be performed under spinal or general anaesthesia in lithotomy position. Antibiotic will be given just before and 12 h after procedure and continued for next 5 days.~Normal saline will be used for irrigation during the procedure. A Holmium laser at an energy of 1,200 to 2.000 mJ with a frequency of 10 to 15 Hz will be used By use of a 22 F cystoscope and Ho:YAG laser, the stricture site will be completely incised while sparing healthy mucosa. a fiber will be positioned about 1 mm away from the tissue and the laser will be fired.~An 18 F silicone Foley catheter will be left in the urethra at the end of the procedure. urethral catheter removal and voiding trial will be given at postoperative Day 7."

PROCEDURE

Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel

"The investigators will follow the same interversion protocol in the first group then paclitaxel is going to be injected via Williams cystoscopic injection needle (5 F size and 23 G needle size) through the cystoscope after laser ablation of the stricture in the submucosa with an assumed dose of 3.5µg/mm2 (reaching a urethral diameter of 30 Fr and a total length of 2 cm a total dose of 2.2 mg divided along 3 injection is to be injected). the dose is divided at 12,4 and 8 o'clock respectively along the length of the stricture.~An 18 F silicone Foley catheter will be left in the urethra at the end of the procedure. urethral catheter removal and voiding trial will be given at postoperative Day 7."

Trial Locations (1)

Unknown

Demerdash hospital, Faculty of medicine, Ain Shams University, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER