Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection

NCT06123520 | Completed Phase 3 DMC

• 1 other identifier: Endoscopic VIU 01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethral Stricture, Male

Keywords

Urethral stricture; Visual internal urethrotomy; Paclitaxel submucosal injection

Outcome Measures

Primary Outcomes (2)

• International prostate symptom score (IPSS) score

  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.

  at 3, 6 months

• uroflowmetry

  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.

  at 3, 6 months

Secondary Outcomes (4)

• assessment of operative time.

  immediately intraoperative.

• assessment of intraoperative bleeding

  immediatly postoperative

• assessment of postoperative infection.

  Patient will be discharged from hospital being 24 hours fever free postoperative.

• assessment of recurrence rate.

  at 3 and 6 months postoperative

Study Arms (2)

Ho-YAG Laser internal urethrotomy

ACTIVE COMPARATOR

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

Procedure: Ho-YAG Laser Visual internal urethrotomy

Ho-YAG Laser internal urethrotomy + Paclitaxel injection

EXPERIMENTAL

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

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

Interventions

Ho-YAG Laser Visual internal urethrotomy 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.

Also known as: Ho-YAG Laser visual internal urethrotomy (VIU)

Ho-YAG Laser internal urethrotomy

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

Also known as: Ho-YAG Laser VIU combined with submucosal Paclitaxel injection

Ho-YAG Laser internal urethrotomy + Paclitaxel injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: urethral stricture in males (urethral stricture in females is rare and has other treatment modalities)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Complete obliteration of lumen of urethra on urethroscopy.
• Multiple strictures.
• Untreated urinary tract infection.
• Recurrent Strictures.
• Prior internal urethrotomy
• Prior urethroplasty
• Compromised upper urinary tract (increased kidney functions)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Demerdash hospital, Faculty of medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Waleed E. Mousa, Assisstant Professor

  AinShams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 8, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 15, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)