Urethral StrictureNCT01982136
Functional Outcome of Urethral Reconstructive Surgery
An observational study of Urethral Stricture, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- end-to-end urethroplasty, substitution urethroplasty (buccal mucosa) and substitution urethroplasty (pedicled skin flap)
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2009to Oct 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: All patients who underwent urethral reconstruction in our center from 2009 to this date
Who may be able to join
- male
- urethral stricture surgery
- informed consent
Who cannot join
- loss of follow-up
- not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Long-term Single Center Cohort Study Assessing Functional Outcome of Urethral Reconstructive Surgery
The analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.
Read the detailed description
Urethroplasty is the surgical repair of a urethral stricture. Depending on the location, severity and length of the stricture, various techniques can be performed.
The first procedure consists of the excision of the stenotic segment and end-to-end anastomosis. Other procedures consist of widening the urethra with buccal mucosa as free graft or with vascularized (genital) skin flaps. The results of these techniques have been described in prospective cohort studies, but to date there is little good data about the functional outcome and quality-of-life with longer follow-up after this surgery.
The purpose of this study is to prospectively follow patients for functional outcome parameters and quality-of-life to obtain long-term information concerning these surgeries.
- Conditions
- Urethral Stricture
- Being tested
- end-to-end urethroplasty, substitution urethroplasty (buccal mucosa), substitution urethroplasty (pedicled skin flap)
- 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-end urethroplastyProcedure or surgery
substitution urethroplasty (buccal mucosa)Procedure or surgery
substitution urethroplasty (pedicled skin flap)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Urethral stricture | patients requiring surgery for urethral stricture Receives: Procedure: end-to-end urethroplasty; Procedure: substitution urethroplasty (buccal mucosa); Procedure: substitution urethroplasty (pedicled skin flap) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life: change from baseline (=preoperative value)
Validated questionnaires (patient reported outcome measures) concerning general discomfort, micturition problems, erections, and the impact of those problems on their social life.
- International Prostate Symptom Score - Quality of Life questionnaire (IPSS-QOL)
- International Consultation of Incontinence - Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSQoL)
Measured: 6m, 1y, 2y, 3y, 4y
Secondary outcomes (2)
Functional outcomes: micturition: change from baseline (=preoperative value)
Validated questionnaires
- International Consultation of Incontinence - Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSQoL)
- Urogenital Distress Inventory short form (UDI-6)
Measured: 6m, 1y, 2y, 3y, 4y
Functional outcomes: erection: change from baseline (=preoperative value)
Validated questionnaires
- International Index of Erectile Dysfunction (IIEF)
Measured: 6m, 1y, 2y, 3y, 4y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startAug 2009
- Primary completionOct 2019
- Study completionOct 2019
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Van der Aa, MD-PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982136
- Sponsor's protocol ID
- ML9859
- Other IDs
- S55868
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2013
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Long-term Single Center Cohort Study Assessing Functional Outcome of Urethral Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT01982136
- Acronym / sponsor ID
- ML9859
- Conditions
- Urethral Stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 13 Nov 2013 (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 analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.
Detailed description
Urethroplasty is the surgical repair of a urethral stricture. Depending on the location, severity and length of the stricture, various techniques can be performed.
The first procedure consists of the excision of the stenotic segment and end-to-end anastomosis. Other procedures consist of widening the urethra with buccal mucosa as free graft or with vascularized (genital) skin flaps. The results of these techniques have been described in prospective cohort studies, but to date there is little good data about the functional outcome and quality-of-life with longer follow-up after this surgery.
The purpose of this study is to prospectively follow patients for functional outcome parameters and quality-of-life to obtain long-term information concerning these surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urethral stricture | – | Procedure: end-to-end urethroplasty, Procedure: substitution urethroplasty (buccal mucosa), Procedure: substitution urethroplasty (pedicled skin flap)patients requiring surgery for urethral stricture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent urethral reconstruction in our center from 2009 to this date
Key inclusion criteria (3 listed)
- male
- urethral stricture surgery
- informed consent
Key exclusion criteria (2 listed)
- loss of follow-up
- not willing to participate
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-end urethroplasty | Procedure or surgery | Urethral stricture |
| substitution urethroplasty (buccal mucosa) | Procedure or surgery | Urethral stricture |
| substitution urethroplasty (pedicled skin flap) | Procedure or surgery | Urethral stricture |
Primary outcome
Quality Of Life: change from baseline (=preoperative value)
Time frame: 6m, 1y, 2y, 3y, 4y
Validated questionnaires (patient reported outcome measures) concerning general discomfort, micturition problems, erections, and the impact of those problems on their social life. * International Prostate Symptom Score - Quality of Life questionnaire (IPSS-QOL) * International Consultation of Incontinence - Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSQoL)
2 secondary outcomes
Functional outcomes: micturition: change from baseline (=preoperative value)
Time frame: 6m, 1y, 2y, 3y, 4y
Functional outcomes: erection: change from baseline (=preoperative value)
Time frame: 6m, 1y, 2y, 3y, 4y
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 29 Oct 2019.
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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.
Frank Van der Aa, MD-PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urethral Stricture, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 29 Oct 2019. 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 Belgium. 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?
Quality Of Life: change from baseline (=preoperative value) (time frame: 6m, 1y, 2y, 3y, 4y). 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 29 Oct 2019.