Role of Paclitaxel in Stricture Urethra

Sponsor

Al-Azhar University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05678413

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stricture Urethra	Procedure: DVIU with paclitaxel injection Procedure: DVIU	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DVIU with paclitaxel 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.	Procedure: DVIU with paclitaxel injection 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.
Active Comparator: DVIU 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.	Procedure: DVIU DVIU

Arm

Intervention/Treatment

Active Comparator: DVIU with paclitaxel

Procedure: DVIU with paclitaxel injection

Active Comparator: DVIU

Procedure: DVIU

DVIU

Outcome Measures

Primary Outcome Measures

Success of treatment [1 year]
Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohamed Fawzy Salman	Cairo		Egypt

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05678413

Other Study ID Numbers:

Intraurethral Paclitaxel

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University

DVIU, Stricture, Paclitaxel

Additional relevant MeSH terms:

Urethral Stricture

Constriction, Pathologic

Paclitaxel

Study Results

No Results Posted as of Jan 10, 2023