Stricture UrethraNCT05678413
Role of Paclitaxel in Stricture Urethra
A study testing DVIU with paclitaxel injection and DVIU in people with Stricture Urethra, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stricture Urethra
- What is being tested?
- DVIU with paclitaxel injection and DVIU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recurrent cases
- Prior pelvic radiation
- Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Fawzy Salman
Cairo
Mohamed Fawzy Salman, MD, +201111788996, prof_mohamed_fawzy@yahoo.com
Aboelfotoh A Aboelfoth, MD
About this study
Official title: Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial
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.
- Conditions
- Stricture Urethra
- Being tested
- DVIU with paclitaxel injection, DVIU
- Keywords
- DVIU, Stricture, Paclitaxel
- Medical subject headings
- Urethral Stricture, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVIU with paclitaxel injectionProcedure or surgery
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.
DVIUProcedure or surgery
DVIU
| Study group | Role | What they receive |
|---|---|---|
| DVIU with paclitaxel | Active comparator | 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. Receives: Procedure: DVIU with paclitaxel injection |
| DVIU | Active comparator | 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. Receives: Procedure: DVIU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of treatment
Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stricture UrethraStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678413
- Sponsor's protocol ID
- Intraurethral Paclitaxel
- Status last verified
- Aug 2024
- First submitted
- 24 Dec 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05678413
- Acronym / sponsor ID
- Intraurethral Paclitaxel
- Conditions
- Stricture Urethra
- Keywords
- DVIU, Stricture, Paclitaxel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DVIU with paclitaxel | Active comparator | Procedure: DVIU with paclitaxel injectionCystourethroscopy 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. |
| DVIU | Active comparator | Procedure: DVIUCystourethroscopy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Recurrent cases
- Prior pelvic radiation
- Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVIU with paclitaxel injectionCystourethroscopy 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 or surgery | DVIU with paclitaxel |
| DVIUDVIU | Procedure or surgery | DVIU |
Primary outcome
Success of treatment
Time frame: 1 year
Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVIU with paclitaxel injection and DVIU in people with Stricture Urethra, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed F Salman, MD (+201111788996, prof_mohamed_fawzy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.