Urethral StricturePhase 1/2NCT00918528
Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
A Phase 1/2 study testing Internal urethrotomy and Mitomycin C - local injection in people with Urethral Stricture, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Internal urethrotomy and Mitomycin C - local injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to not given
- Phase
- Phase 1/2
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male urethral stricture suitable for internal urethrotomy
- Stricture length less than 10 mm
Who cannot join
- Stricture length over 10 mm
- Benign prostate enlargement
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Michael Mullerad, MD, 972-4-630-4440
Nachum Erlich, MD, 972-4-630-4440, erlichn@hy.health.gov.il
About this study
The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.
- Conditions
- Urethral Stricture
- Being tested
- Internal urethrotomy, Mitomycin C - local injection
- Keywords
- Urethral stricture, Mitomycin C, Internal Urethrotomy
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal urethrotomyProcedure or surgery
Mitomycin C - local injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| 1. Internal urethrotomy | Active comparator | Not described Receives: Procedure: Internal urethrotomy |
| 2. Internal urethrotomy + mitomycin C | Experimental | Not described Receives: Procedure: Internal urethrotomy; Drug: Mitomycin C - local injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral stricture recurrence
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918528
- Sponsor's protocol ID
- 0020-09-HYMC
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 11 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
- ClinicalTrials.gov ID
- NCT00918528
- Acronym / sponsor ID
- 0020-09-HYMC
- Conditions
- Urethral Stricture
- Keywords
- Urethral stricture, Mitomycin C, Internal Urethrotomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2009
- First posted
- 11 Jun 2009 (estimated)
- 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 aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Internal urethrotomy | Active comparator | Procedure: Internal urethrotomy |
| 2. Internal urethrotomy + mitomycin C | Experimental | Procedure: Internal urethrotomy, Drug: Mitomycin C - local injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male urethral stricture suitable for internal urethrotomy
- Stricture length less than 10 mm
Key exclusion criteria (2 listed)
- Stricture length over 10 mm
- Benign prostate enlargement
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 |
|---|---|---|
| Internal urethrotomy | Procedure or surgery | 1. Internal urethrotomy, 2. Internal urethrotomy + mitomycin C |
| Mitomycin C - local injection | Drug | 2. Internal urethrotomy + mitomycin C |
Primary outcome
Urethral stricture recurrence
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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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 Phase 1/2 study testing Internal urethrotomy and Mitomycin C - local injection in people with Urethral Stricture, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 11 Jun 2009. 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 Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethral stricture recurrence (time frame: One 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 11 Jun 2009; AzTrials last refreshed its copy on 6 Nov 2026.