Urethral StricturesPhase 4IUNCT01196572
Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
A Phase 4 study testing Internal Urethrotomy in people with Urethral Strictures, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether laser internal urethrotomy (IU) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Strictures
- What is being tested?
- Internal Urethrotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Sep 2013
- Phase
- Phase 4
- 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
- Men over 18 years old with urethral stricture
Who cannot join
- S/P urethral reconstruction
- Posterior urethral strictures
- Children
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba_Medical_Center
Ramat Gan
Barak Rosenzweig, Dr., 00-972-3-5302239, barak22@gmail.com
About this study
Official title: Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
The purpose of this study is to determine whether laser internal urethrotomy (IU) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications
Read the detailed description
The current surgical treatment for anterior urethral stricture includes internal urethrotomy (IU) by cold knife. Recurrence rate after such procedure is quoted as 35-70% in 2 to 5 years follow-up. Possible surgical alternative procedures include: open surgical urethral re-construction, urethral stents usage \& laser IU. According to existing data (Nd-YAG laser- retrospective) the recurrence rate after laser IU is far better comparing to cold knife urethrotomy. The current research intends to address this question using prospective randomized methods.
- Conditions
- Urethral Strictures
- Being tested
- Internal Urethrotomy
- Keywords
- stricture, urethra, laser, urethrotomy, holmium, bladder outlet obstruction
- Medical subject headings
- Urethral Stricture, Constriction, Pathologic, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal UrethrotomyProcedure or surgery
Also called Holmium laser
surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser
| Study group | Role | What they receive |
|---|---|---|
| Laser IU | Experimental | Urethral stricture incised by Holmium laser Receives: Procedure: Internal Urethrotomy |
| Cold knife IU | Active comparator | Urethral stricture incised by knife Receives: Procedure: Internal Urethrotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
Urethral stricture \& urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry \& clinical questionnaire (IPSS).
Measured: up to 2 years
Secondary outcomes (1)
post operative complications
Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion \& re-operations will be assessed.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StricturesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196572
- Sponsor's protocol ID
- SHEBA-10-7897-ZD-CTIL
- Acronym
- IU
- Status last verified
- Aug 2011
- First submitted
- 4 Sep 2010
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
- ClinicalTrials.gov ID
- NCT01196572
- Acronym / sponsor ID
- IU / SHEBA-10-7897-ZD-CTIL
- Conditions
- Urethral Strictures
- Keywords
- stricture, urethra, laser, urethrotomy, holmium, bladder outlet obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 Sep 2010 (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 purpose of this study is to determine whether laser internal urethrotomy (IU) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications
Detailed description
The current surgical treatment for anterior urethral stricture includes internal urethrotomy (IU) by cold knife. Recurrence rate after such procedure is quoted as 35-70% in 2 to 5 years follow-up. Possible surgical alternative procedures include: open surgical urethral re-construction, urethral stents usage \& laser IU. According to existing data (Nd-YAG laser- retrospective) the recurrence rate after laser IU is far better comparing to cold knife urethrotomy. The current research intends to address this question using prospective randomized methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser IU | Experimental | Procedure: Internal UrethrotomyUrethral stricture incised by Holmium laser |
| Cold knife IU | Active comparator | Procedure: Internal UrethrotomyUrethral stricture incised by knife |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men over 18 years old with urethral stricture
Key exclusion criteria (3 listed)
- S/P urethral reconstruction
- Posterior urethral strictures
- Children
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 UrethrotomyAlso: Holmium lasersurgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser | Procedure or surgery | Cold knife IU, Laser IU |
Primary outcome
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
Time frame: up to 2 years
Urethral stricture \& urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry \& clinical questionnaire (IPSS).
1 secondary outcome
post operative complications
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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 4 study testing Internal Urethrotomy in people with Urethral Strictures, run by Sheba 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 1 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 9 Aug 2011. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction (time frame: up to 2 years). 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 9 Aug 2011.