search
Back to results

Role of Paclitaxel in Stricture Urethra

Primary Purpose

Stricture Urethra

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
DVIU with paclitaxel injection
DVIU
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stricture Urethra focused on measuring DVIU, Stricture, Paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Anterior urethral stricture Short strictures (less than 2 cm) International Prostate Symptom Score less than 11 and maximum flow rate < 15 ml per second. No previous treatment for stricture disease Exclusion Criteria: Recurrent cases Prior pelvic radiation Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.

Sites / Locations

  • Mohamed Fawzy SalmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DVIU with paclitaxel

DVIU

Arm Description

Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.

Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue.

Outcomes

Primary Outcome Measures

Success of treatment
Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).

Secondary Outcome Measures

Full Information

First Posted
December 24, 2022
Last Updated
January 9, 2023
Sponsor
Al-Azhar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05678413
Brief Title
Role of Paclitaxel in Stricture Urethra
Official Title
Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stricture urethra is a common disease and has various causing factors. The most common performed procedure is direct visual internal urethrotomy (DVIU), but unfortunately has a high recurrence rates. Multiple trial were performed to improve the outcomes of DVIU. Various intralesional injections were used. in this trial we will evaluate intralesional paclitaxel injection following DVIU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stricture Urethra
Keywords
DVIU, Stricture, Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DVIU with paclitaxel
Arm Type
Active Comparator
Arm Description
Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.
Arm Title
DVIU
Arm Type
Active Comparator
Arm Description
Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue.
Intervention Type
Procedure
Intervention Name(s)
DVIU with paclitaxel injection
Intervention Description
Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.
Intervention Type
Procedure
Intervention Name(s)
DVIU
Intervention Description
DVIU
Primary Outcome Measure Information:
Title
Success of treatment
Description
Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anterior urethral stricture Short strictures (less than 2 cm) International Prostate Symptom Score less than 11 and maximum flow rate < 15 ml per second. No previous treatment for stricture disease Exclusion Criteria: Recurrent cases Prior pelvic radiation Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
Facility Information:
Facility Name
Mohamed Fawzy Salman
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Fawzy Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Aboelfotoh A Aboelfoth, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Role of Paclitaxel in Stricture Urethra

We'll reach out to this number within 24 hrs