Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection
Condition: Urethral Stricture, Male
MeSH terms: Urethral Stricture; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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

        1. Detailed history taking, including medical history, surgical history, and patient
           complaint according to international prostate symptom score (IPSS) score. A note will be
           made about the possible etiology of the stricture.

        2. Clinical Examination including abdominal, pelvic and genital examination.

        3. Laboratory investigations including complete blood count, urine analysis, urine culture
           and sensitivity test, renal function tests.

        4. Radiological investigations including retrograde urethrogram, micturating
           cystourethrogram and pelvi-abdominal ultrasound.

        5. Uroflowmetry

      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.
    

Intervention name(s): Ho-YAG Laser Visual internal urethrotomy; Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Ho-YAG Laser visual internal urethrotomy (VIU); Ho-YAG Laser VIU combined with submucosal Paclitaxel injection
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urethral stricture; Visual internal urethrotomy; Paclitaxel submucosal injection