Urethral StrictureSUPSNCT02321670
Scandinavian Urethroplasty Study
A study testing End-to-end and Graft in people with Urethral Stricture, run by Oslo University Hospital at 4 sites in 3 countries.
Trial summary
A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- End-to-end and Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2015to 15 Feb 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm
- Patient is able and willing to sign informed consent
- Patient is able and willing to complete all study requirements
Who cannot join
- Previous open urethroplasty
- Previous hypospadia surgery
- Previous surgery for congenital curvature or Mb Peyronie
- Previous pelvic irradiation therapy
- Known grave psychiatric disorder
- Haemophilia or other clotting disorders that cause bleeding diathesis
- Use of medication to increase erectile function, such as PDE5-inhibitors and intracavernous injections, during the study
- Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites
Sahlgrenska University Hospital, Dept of Urology
Gothenburg, 41345
Örebro University Hospital, Dept of Urology
Örebro, 70185
About this study
Official title: Scandinavian Urethroplasty Study. A Multicentre, Prospective, Randomized Study Comparing Bulbar Urethroplasty With Excision and Primary Anastomosis or With an Onlay Grafting Procedure Using Buccal Mucosa.
A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.
Read the detailed description
The study is a prospective, randomized study to compare two common techniques of urethroplasty used to treat bulbar urethral strictures. One technique is excision of the stricture and end-to-end anastomosis of the urethra. The other technique is an onlay grafting procedure with buccal mucosa where the corpus spongiosum is not divided. The study is designed to compare complications of sexual and penile function, and is not powered to compare the success rates of the two techniques. The primary endpoint will be degree of erectile dysfunction and penile complications. The secondary endpoint will be restricturing leading to reoperation, and other complications.
- Conditions
- Urethral Stricture
- Being tested
- End-to-end, Graft
- Keywords
- operative technique
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-to-endProcedure or surgery
Excision of the stricture and end-to-end anastomosis of the urethra.
GraftProcedure or surgery
Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided
| Study group | Role | What they receive |
|---|---|---|
| End-to-end | Active comparator | Excision of the stricture and end-to-end anastomosis of the urethra. Receives: Procedure: End-to-end |
| Graft | Active comparator | Incision of the stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided. Receives: Procedure: Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of erectile dysfunction after surgery
Measured by changes in IIEF-5
Measured: up to one year
Penile complications
Measured by questionnaire made for this study
Measured: up to one year
Secondary outcomes (2)
Occurrence of failure within the follow up period
Measured: One year
Occurrence of complications
Measured: From operation to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startSep 2015
- Primary completion31 Jan 2021
- Study completion15 Feb 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 Oslo University HospitalThe 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
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Region Örebro County, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Ole Jacob Nilsen, Oslo University Hospital
- Investigators
- Alexander Schultz, MD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321670
- Sponsor's protocol ID
- OUS-URO-SUPS
- Acronym
- SUPS
- Status last verified
- Oct 2021
- First submitted
- 17 Dec 2014
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Urethroplasty Study. A Multicentre, Prospective, Randomized Study Comparing Bulbar Urethroplasty With Excision and Primary Anastomosis or With an Onlay Grafting Procedure Using Buccal Mucosa.
- ClinicalTrials.gov ID
- NCT02321670
- Acronym / sponsor ID
- SUPS / OUS-URO-SUPS
- Conditions
- Urethral Stricture
- Keywords
- operative technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Region Örebro County, Helsinki University Central Hospital
- Study start
- Sep 2015 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 22 Dec 2014 (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.
A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.
Detailed description
The study is a prospective, randomized study to compare two common techniques of urethroplasty used to treat bulbar urethral strictures. One technique is excision of the stricture and end-to-end anastomosis of the urethra. The other technique is an onlay grafting procedure with buccal mucosa where the corpus spongiosum is not divided. The study is designed to compare complications of sexual and penile function, and is not powered to compare the success rates of the two techniques. The primary endpoint will be degree of erectile dysfunction and penile complications. The secondary endpoint will be restricturing leading to reoperation, and other complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-to-end | Active comparator | Procedure: End-to-endExcision of the stricture and end-to-end anastomosis of the urethra. |
| Graft | Active comparator | Procedure: GraftIncision of the stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm
- Patient is able and willing to sign informed consent
- Patient is able and willing to complete all study requirements
Key exclusion criteria (8 listed)
- Previous open urethroplasty
- Previous hypospadia surgery
- Previous surgery for congenital curvature or Mb Peyronie
- Previous pelvic irradiation therapy
- Known grave psychiatric disorder
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 |
|---|---|---|
| End-to-endExcision of the stricture and end-to-end anastomosis of the urethra. | Procedure or surgery | End-to-end |
| GraftIncision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided | Procedure or surgery | Graft |
Primary outcome
Degree of erectile dysfunction after surgery
Time frame: up to one year
Measured by changes in IIEF-5
Penile complications
Time frame: up to one year
Measured by questionnaire made for this study
2 secondary outcomes
Occurrence of failure within the follow up period
Time frame: One year
Occurrence of complications
Time frame: From operation to one year
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 3 Nov 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.
Alexander Schultz, MD principal investigator
Consultant
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-to-end and Graft in people with Urethral Stricture, run by Oslo University Hospital at 4 sites in 3 countries.
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 8 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Finland, Norway. 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?
Degree of erectile dysfunction after surgery (time frame: up to one year). 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 3 Nov 2021.