Urethral Stricture, MalePhase 3NCT06123520
Laser Visual Internal Urethrotomy With Versus Without Paclitaxel Injection
A Phase 3 study testing Ho-YAG Laser Visual internal urethrotomy and Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel in people with Urethral Stricture, Male, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urethral Stricture, Male
- What is being tested?
- Ho-YAG Laser Visual internal urethrotomy and Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 15 Oct 2023
- Phase
- Phase 3
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Holmium Laser Urethrotomy Versus in Combination With Intralesional Paclitaxel Injection in the Treatment of Urethral Stricture
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.
Read the 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
- 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.
- Clinical Examination including abdominal, pelvic and genital examination.
- Laboratory investigations including complete blood count, urine analysis, urine culture and sensitivity test, renal function tests.
- Radiological investigations including retrograde urethrogram, micturating cystourethrogram and pelvi-abdominal ultrasound.
- 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
- Being tested
- Ho-YAG Laser Visual internal urethrotomy, Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel
- Keywords
- Urethral stricture, Visual internal urethrotomy, Paclitaxel submucosal injection
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ho-YAG Laser Visual internal urethrotomyProcedure or surgery
Also called Ho-YAG Laser visual internal urethrotomy (VIU)
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 Visual internal urethrotomy combined with intralesional submucosal injection of PaclitaxelProcedure or surgery
Also called Ho-YAG Laser VIU combined with submucosal Paclitaxel injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Ho-YAG Laser internal urethrotomy | Active comparator | consists of those who will undergo Ho-YAG laser internal urethrotomy only. Receives: 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. Receives: Procedure: Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 3, 6 months
Secondary outcomes (4)
assessment of operative time.
assessment of operative time.
Measured: immediately intraoperative.
assessment of intraoperative bleeding
amount of blood loss intraoperative with comparing preoperative and postoperative haemoglobin levels and the need of intraoperative blood transfusion.
Measured: immediatly postoperative
assessment of postoperative infection.
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 and the time of discharge from hospital to calculate hospital stay time based upon being 24 hours fever free with no bleeding postoperatively or until the correction of such conditions (resolution of fever and stopping the bleeding with correction of haemoglobin level).
Measured: Patient will be discharged from hospital being 24 hours fever free postoperative.
assessment of recurrence rate.
if the patient is retained (could not urinate) or his results in IPSS or Uroflowmetry were worse than starting results, then cystourethrogram will be asked from him to investigate the possibility of recurrence of urethral stricture.
Measured: at 3 and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 May 2023
- Primary completion1 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Stricture, MaleStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Waleed E. Mousa, Assisstant Professor, Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123520
- Sponsor's protocol ID
- Endoscopic VIU 01
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Holmium Laser Urethrotomy Versus in Combination With Intralesional Paclitaxel Injection in the Treatment of Urethral Stricture
- ClinicalTrials.gov ID
- NCT06123520
- Acronym / sponsor ID
- Endoscopic VIU 01
- Conditions
- Urethral Stricture, Male
- Keywords
- Urethral stricture, Visual internal urethrotomy, Paclitaxel submucosal injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 8 Nov 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.
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
- 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.
- Clinical Examination including abdominal, pelvic and genital examination.
- Laboratory investigations including complete blood count, urine analysis, urine culture and sensitivity test, renal function tests.
- Radiological investigations including retrograde urethrogram, micturating cystourethrogram and pelvi-abdominal ultrasound.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ho-YAG Laser internal urethrotomy | Active comparator | Procedure: Ho-YAG Laser Visual internal urethrotomyconsists of those who will undergo Ho-YAG laser internal urethrotomy only. |
| Ho-YAG Laser internal urethrotomy + Paclitaxel injection | Experimental | Procedure: Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxelthose who will undergo Ho-YAG laser internal urethrotomy with circumferential submucosal paclitaxel injection at the stricture site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Complete obliteration of lumen of urethra on urethroscopy.
- Multiple strictures.
- Untreated urinary tract infection.
- Recurrent Strictures.
- Prior internal urethrotomy
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 |
|---|---|---|
| Ho-YAG Laser Visual internal urethrotomyAlso: Ho-YAG Laser visual internal urethrotomy (VIU)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. | Procedure or surgery | Ho-YAG Laser internal urethrotomy |
| Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of PaclitaxelAlso: Ho-YAG Laser VIU combined with submucosal Paclitaxel injectionThe 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. | Procedure or surgery | Ho-YAG Laser internal urethrotomy + Paclitaxel injection |
Primary outcome
International prostate symptom score (IPSS) score
Time frame: at 3, 6 months
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.
uroflowmetry
Time frame: at 3, 6 months
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.
4 secondary outcomes
assessment of operative time.
Time frame: immediately intraoperative.
assessment of intraoperative bleeding
Time frame: immediatly postoperative
assessment of postoperative infection.
Time frame: Patient will be discharged from hospital being 24 hours fever free postoperative.
assessment of recurrence rate.
Time frame: at 3 and 6 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Waleed E. Mousa, Assisstant Professor study director
AinShams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ho-YAG Laser Visual internal urethrotomy and Ho-YAG Laser Visual internal urethrotomy combined with intralesional submucosal injection of Paclitaxel in people with Urethral Stricture, Male, run by Ain Shams 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 7 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: finished, as of the sponsor's last update on 8 Nov 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International prostate symptom score (IPSS) score (time frame: at 3, 6 months). The study lists 2 primary outcomes in all. 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 8 Nov 2023.