A Phase 3 interventional study of Ho-YAG Laser Visual internal urethrotomy and Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel in Urethral Stricture, Male, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
To evaluate the outcome of visual internal urethrotomy in treating urethral strictures in males with a holmium: yttrium-aluminium garnet (YAG) laser versus when combined with intralesional injection of paclitaxel.
Urethral strictures are one of the most common reasons for urological admissions. They are associated with urinary tract infections, bladder stones, fistulas, sepsis and possibly renal insufficiency. Minimally invasive surgical approaches are utilized efficiently and safely in the treatment of urethral strictures. Visualized internal urethrotomy VIU, is one of the preferred methods due to the practical and minimally invasive nature of the procedure. One of the alternative approaches is the correction of the stricture using laser energy. The aim of this prospective study is to evaluate the results of YAG laser internal urethrotomy (HIU) in primary urethral strictures versus using laser with intralesional submucosal paclitaxel injection.
It is a prospective study in which patients will be recruited from the outpatient clinic of Demerdash (ain Shams university) hospital, randomized via closed envelope technique into doing VIU alone versus doing VIU with intralesional injection of paclitaxel
After obtaining well informed written consent, all patients will undergo the following
Any active urinary tract infection (UTI) will be treated before surgery with appropriate antibiotics based upon sensitivity test.
All patients will be followed up intraoperatively recording operative time and the need for blood transfusion, postopertively regarding haemoglobin level, total leucocytic count level and the development of fever or not. All patients will be scheduled to remove the catheter at 14 days postoperative and assessment of international prostate symptom score (IPSS) at first day of catheter removal.
Three months and six months postoperative the patients will be followed up for IPSS, Uroflowmetry results and if the patient is retained (could not urinate) or his results were worse than starting results, then cystourethrogram will be asked from him to investigate the possibility of recurrence.
68 studies on the registry are indexed under Urethral Stricture; 23 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 53 interventional studies indexed under Urethral Stricture.
Browse Urethral Stricture studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Exclusion criteria used were:
consists of those who will undergo Ho-YAG laser internal urethrotomy only.
Procedure: Ho-YAG Laser Visual internal urethrotomy
those who will undergo Ho-YAG laser internal urethrotomy with circumferential submucosal paclitaxel injection at the stricture site.
Procedure: Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel
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.
Also known as: Ho-YAG Laser visual internal urethrotomy (VIU)
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.
Also known as: Ho-YAG Laser VIU combined with submucosal Paclitaxel injection
International prostate symptom score (IPSS) score
Clinical effectiveness in improving patient reported lower urinary tract symptoms according to IPSS with a score from 0 to 35 by answering 7 questions, each question with a 0 till 5 points with total score from 0 till 35. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time frame: at 3, 6 months
uroflowmetry
the quantitative assessment of the flow of urine using uroflowmetry with a score higher than 15 ml/sec indicating no obstruction while from 0-10 indicates obstructed flow and between 10 to 15 obstruction is suspected requiring further investigations.
Time frame: at 3, 6 months
assessment of operative time.
assessment of operative time.
Time frame: immediately intraoperative.
assessment of intraoperative bleeding
amount of blood loss intraoperative with comparing preoperative and postoperative haemoglobin levels and the need of intraoperative blood transfusion.
Time frame: immediatly postoperative
assessment of postoperative infection.
All patients will be followed up intraoperatively recording operative time and the need for blood transfusion, postopertively regarding haemoglobin level, total leucocytic count level and the development of fever or not and the time of discharge from hospital to calculate hospital stay time based upon being 24 hours fever free with no bleeding postoperatively or until the correction of such conditions (resolution of fever and stopping the bleeding with correction of haemoglobin level).
Time frame: Patient will be discharged from hospital being 24 hours fever free postoperative.
assessment of recurrence rate.
if the patient is retained (could not urinate) or his results in IPSS or Uroflowmetry were worse than starting results, then cystourethrogram will be asked from him to investigate the possibility of recurrence of urethral stricture.
Time frame: at 3 and 6 months postoperative
Plan to share: No
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Ain Shams University