Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06123520 |
Other study ID # |
Endoscopic VIU 01 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
October 15, 2023 |
Study information
Verified date |
November 2023 |
Source |
Ain Shams University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.