HypospadiasNCT02103712
Long Term Outcome of Hypospadias Repair
An observational study of Hypospadias, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. The opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. Read more about this study
- Who is it for?
- Ages 3 to 17 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Qualitative
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2012to 30 Sep 2013
- 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 3 to 17 years
- Men only
- No healthy volunteers
- Child
Study population: Patients with hypospadias
Who may be able to join
- 1 Patients with hypospadias who have been treated one of the following two surgical proceduresStandard Tubularised Incised Plate (TIP) operation (Group A) or Tubularised Incised Plate (TIP) procedure incorporating a free graft of preputial skin (in a layer of foreskin) into the urethral reconstruction (Group B ) 2 The study will be confined to primary operations. Patients in whom either of the techniques was used for a secondary or 'redo' procedure will be excluded from the study.
- 3 The study will be confined to boys over 3 years of age who are potty trained and able to pass urine for the non invasive flow rate test .
Who cannot join
- 1 Patients whose hypospadias was corrected using some technique other than 'standard' or 'grafted' TIP repair.
- 2 "Redo" cases 3 Boys under 3 years at the time of the study or patients who do not have full bladder control for some other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Outcome of Hypospadias Repair: A Comparative Study
Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. The opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. Although the most commonly practised corrective operation ( TIP procedure) gives generally good results, recently published evidence points to a possible long term risk of stenosis ( narrowing of the reconstructed urethra). This comparative study will combine clinical assessment with non invasive measurements of urinary flow to assess the functional outcome of a large series of patients who have undergone hypospadias surgery . The study is primarily designed to answer this question : does a modification of the standard operation which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow and a decreased risk of stenosis? This has not been previously studied . The findings of our study could make an important contribution to improvements in the surgical treatment of boys born with hypospadias.
- Conditions
- Hypospadias
- Being tested
- Qualitative
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QualitativeOther
| Study group | Role | What they receive |
|---|---|---|
| Hypospadias | Not described Receives: Other: Qualitative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does a modification of the standard TIP hypospadias operation which incorporates a skin graft into the reconstructed urethra result in improved urinary flow and a (presumed)decrease in the long term risk of stenosis?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start1 Oct 2012
- Primary completion30 Sep 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103712
- Sponsor's protocol ID
- UR12/10496
- Status last verified
- Aug 2019
- First submitted
- 20 Nov 2013
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome of Hypospadias Repair: A Comparative Study
- ClinicalTrials.gov ID
- NCT02103712
- Acronym / sponsor ID
- UR12/10496
- Conditions
- Hypospadias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 4 Apr 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.
Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. The opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. Although the most commonly practised corrective operation ( TIP procedure) gives generally good results, recently published evidence points to a possible long term risk of stenosis ( narrowing of the reconstructed urethra). This comparative study will combine clinical assessment with non invasive measurements of urinary flow to assess the functional outcome of a large series of patients who have undergone hypospadias surgery . The study is primarily designed to answer this question : does a modification of the standard operation which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow and a decreased risk of stenosis? This has not been previously studied . The findings of our study could make an important contribution to improvements in the surgical treatment of boys born with hypospadias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypospadias | – | Other: Qualitative |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with hypospadias
Key inclusion criteria (2 listed)
- 1 Patients with hypospadias who have been treated one of the following two surgical proceduresStandard Tubularised Incised Plate (TIP) operation (Group A) or Tubularised Incised Plate (TIP) procedure incorporating a free graft of preputial skin (in a layer of foreskin) into the urethral reconstruction (Group B ) 2 The study will be confined to primary operations. Patients in whom either of the techniques was used for a secondary or 'redo' procedure will be excluded from the study.
- 3 The study will be confined to boys over 3 years of age who are potty trained and able to pass urine for the non invasive flow rate test .
Key exclusion criteria (2 listed)
- 1 Patients whose hypospadias was corrected using some technique other than 'standard' or 'grafted' TIP repair.
- 2 "Redo" cases 3 Boys under 3 years at the time of the study or patients who do not have full bladder control for some other reason.
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 |
|---|---|---|
| Qualitative | Other | Hypospadias |
Primary outcome
Does a modification of the standard TIP hypospadias operation which incorporates a skin graft into the reconstructed urethra result in improved urinary flow and a (presumed)decrease in the long term risk of stenosis?
Time frame: 1 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 19 Aug 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.
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?
An observational study of Hypospadias, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 19 Aug 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 United Kingdom. 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?
Does a modification of the standard TIP hypospadias operation which incorporates a skin graft into the reconstructed urethra result in improved urinary flow and a (presumed)decrease in the long term risk of stenosis? (time frame: 1 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 19 Aug 2019.