Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection

NCT ID: NCT06123520

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-10-15

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.

Conditions

Urethral Stricture, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ho-YAG Laser internal urethrotomy

consists of those who will undergo Ho-YAG laser internal urethrotomy only.

Group Type: ACTIVE_COMPARATOR

Ho-YAG Laser Visual internal urethrotomy

Intervention Type: PROCEDURE

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.

Ho-YAG Laser internal urethrotomy + Paclitaxel injection

those who will undergo Ho-YAG laser internal urethrotomy with circumferential submucosal paclitaxel injection at the stricture site.

Group Type: EXPERIMENTAL

Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel

Intervention Type: PROCEDURE

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.

Interventions

Ho-YAG Laser Visual internal urethrotomy

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.

Intervention Type: PROCEDURE

Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel

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.

Intervention Type: PROCEDURE

Other Intervention Names

Ho-YAG Laser visual internal urethrotomy (VIU); Ho-YAG Laser VIU combined with submucosal Paclitaxel injection

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Younan Ramsis

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waleed E. Mousa, Assisstant Professor

Role: STUDY_DIRECTOR

AinShams University

Locations

Demerdash hospital, Faculty of medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Endoscopic VIU 01

Identifier Type: -

Identifier Source: org_study_id