Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection
- Conditions
- Urethral Stricture, Male
- Interventions
- Procedure: Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of PaclitaxelProcedure: Ho-YAG Laser Visual internal urethrotomy
- Registration Number
- NCT06123520
- Lead Sponsor
- Ain Shams University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ho-YAG Laser internal urethrotomy + Paclitaxel injection Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel those who will undergo Ho-YAG laser internal urethrotomy with circumferential submucosal paclitaxel injection at the stricture site. Ho-YAG Laser internal urethrotomy Ho-YAG Laser Visual internal urethrotomy consists of those who will undergo Ho-YAG laser internal urethrotomy only.
- Primary Outcome Measures
Name Time Method International prostate symptom score (IPSS) score at 3, 6 months 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.
uroflowmetry at 3, 6 months 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.
- Secondary Outcome Measures
Name Time Method assessment of postoperative infection. Patient will be discharged from hospital being 24 hours fever free postoperative. 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).
assessment of intraoperative bleeding immediatly postoperative amount of blood loss intraoperative with comparing preoperative and postoperative haemoglobin levels and the need of intraoperative blood transfusion.
assessment of operative time. immediately intraoperative. assessment of operative time.
assessment of recurrence rate. at 3 and 6 months postoperative 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.
Trial Locations
- Locations (1)
Demerdash hospital, Faculty of medicine, Ain Shams University
🇪🇬Cairo, Egypt