Urethral StrictureNCT05078788
Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture
A study testing Laser uretherotomy and Laser uretherotomy with triamcinolone in people with Urethral Stricture, run by Ain Shams University at 1 site in Egypt.
Trial summary
the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection. Read more about this study
- Who is it for?
- Ages 26 to 69 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Laser uretherotomy and Laser uretherotomy with triamcinolone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2020to 10 Sep 2021
- 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 26 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of obstructive symptoms,
- Short segment strictures (stricture length <2 cm) as evident on radiological studies, i.e. retrograde urethrography and micturating cystourethrography.
- Peak flow rate on uroflowmetry less than 15 ml/s
Who cannot join
- Complete obliteration of lumen of urethra on urethroscopy,
- Balanitis Xerotica Obliterans,
- Age less than 18 years,
- Multiple strictures,
- Active urinary tract infection,
- Recurrent Strictures.
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- Prior internal uretherotomy
- Prior urethroplasty
- Pan-anterior urethral strictures
- Posterior stenosis
- Those who lost to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Holmium Laser Uretherotomy in Combination With Intralesional Steroids in the Treatment of Bulbar Uretheral Stricture
the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.
Read the detailed description
In this study, the investigator evaluates the efficacy of Holmium laser in combination with intra lesional steroid injection in the treatment of bulbar urethral strictures
- Conditions
- Urethral Stricture
- Being tested
- Laser uretherotomy, Laser uretherotomy with triamcinolone
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser uretherotomyProcedure or surgery
Holmium YAG Laser with pulse energy from 1-2 Joule, frequency from 10-15 Hertz and total power from 3.0 to 30.0 Watt were set up, respectively, based on the extent of the lesions. Scar tissue was incised at the position of 12-o'clock under the guidance of guidewire or ureteric catheter till fresh mucosa appeared.
Laser uretherotomy with triamcinoloneProcedure or surgery
After laser urethrotomy, 80 mg of triamcinolone (diluted with normal saline to 10 ml) will be injected by using an injection needle (5 F size and 23 G needle size) at 10 sites, 1 ml each, along the site of urethrotomy and circumferentially.
| Study group | Role | What they receive |
|---|---|---|
| Laser uretherotomy | Experimental | Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture Receives: Procedure: Laser uretherotomy |
| Laser uretherotomy with intralesional steroids | Experimental | Using holmium laser uretherotomy with injection of 80 mg of triamcinolone (diluted with normal saline to 10 ml) in the treatment of bulbar uretheral stricture Receives: Procedure: Laser uretherotomy with triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
The procedure will be accepted as successful when the maximum flow rate (Qmax) is >15 ml/s.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start2 Jun 2020
- Primary completion2 Feb 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078788
- Sponsor's protocol ID
- M D 98/ 2020
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Holmium Laser Uretherotomy in Combination With Intralesional Steroids in the Treatment of Bulbar Uretheral Stricture
- ClinicalTrials.gov ID
- NCT05078788
- Acronym / sponsor ID
- M D 98/ 2020
- Conditions
- Urethral Stricture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 15 Oct 2021 (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.
the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.
Detailed description
In this study, the investigator evaluates the efficacy of Holmium laser in combination with intra lesional steroid injection in the treatment of bulbar urethral strictures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser uretherotomy | Experimental | Procedure: Laser uretherotomyUsing Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture |
| Laser uretherotomy with intralesional steroids | Experimental | Procedure: Laser uretherotomy with triamcinoloneUsing holmium laser uretherotomy with injection of 80 mg of triamcinolone (diluted with normal saline to 10 ml) in the treatment of bulbar uretheral stricture |
Who may qualify
- Ages
- 26 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of obstructive symptoms,
- Short segment strictures (stricture length <2 cm) as evident on radiological studies, i.e. retrograde urethrography and micturating cystourethrography.
- Peak flow rate on uroflowmetry less than 15 ml/s
Key exclusion criteria (11 listed)
- Complete obliteration of lumen of urethra on urethroscopy,
- Balanitis Xerotica Obliterans,
- Age less than 18 years,
- Multiple strictures,
- Active urinary tract infection,
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 |
|---|---|---|
| Laser uretherotomyHolmium YAG Laser with pulse energy from 1-2 Joule, frequency from 10-15 Hertz and total power from 3.0 to 30.0 Watt were set up, respectively, based on the extent of the lesions. Scar tissue was incised at the position of 12-o'clock under the guidance of guidewire or ureteric catheter till fresh mucosa appeared. | Procedure or surgery | Laser uretherotomy |
| Laser uretherotomy with triamcinoloneAfter laser urethrotomy, 80 mg of triamcinolone (diluted with normal saline to 10 ml) will be injected by using an injection needle (5 F size and 23 G needle size) at 10 sites, 1 ml each, along the site of urethrotomy and circumferentially. | Procedure or surgery | Laser uretherotomy with intralesional steroids |
Primary outcome
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
Time frame: 3 and 6 months
The procedure will be accepted as successful when the maximum flow rate (Qmax) is >15 ml/s.
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 15 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser uretherotomy and Laser uretherotomy with triamcinolone in people with Urethral Stricture, 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 3 inclusion and 11 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 15 Oct 2021. 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?
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?
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure (time frame: 3 and 6 months). 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 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.