Clinical trial NCT06123520: Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection
Official title: Efficacy of Holmium Laser Urethrotomy Versus in Combination With Intralesional Paclitaxel Injection in the Treatment of Urethral Stricture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urethral Stricture, Male
Keywords: Urethral stricture
Visual internal urethrotomy
Paclitaxel submucosal injection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. Adult male
2. Presence of obstructive symptoms (moderate to severe according to IPSS scoring system i.e. \>7)
3. Single urethral (stricture length \<1.5 cm) as evident on radiological studies, i.e., retrograde urethrography (RGU) and micturating cystourethrography (MCU).
4. Average flow rate on uroflowmetry less than 10 ml/s

Exclusion criteria used were:

1. Complete obliteration of lumen of urethra on urethroscopy.
2. Multiple strictures.
3. Untreated urinary tract infection.
4. Recurrent Strictures.
5. Prior internal urethrotomy
6. Prior urethroplasty
7. Compromised upper urinary tract (increased kidney functions)

Primary outcomes:
measure: International prostate symptom score (IPSS) score
timeFrame: at 3, 6 months
measure: uroflowmetry
timeFrame: at 3, 6 months
Secondary outcomes:
measure: assessment of operative time.
timeFrame: immediately intraoperative.
measure: assessment of intraoperative bleeding
timeFrame: immediatly postoperative
measure: assessment of postoperative infection.
timeFrame: Patient will be discharged from hospital being 24 hours fever free postoperative.
measure: assessment of recurrence rate.
timeFrame: at 3 and 6 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Demerdash hospital, Faculty of medicine, Ain Shams University
Study officials:
affiliation: AinShams University
name: Waleed E. Mousa, Assisstant Professor
role: STUDY_DIRECTOR
References: