HypospadiasNCT05032222
The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
An observational study of Hypospadias, run by Mohammad Alaa Ezzat at 1 site in Egypt.
Trial summary
Hypospadias is a common anomaly of the male genitalia affecting 0.4-8.2 of 1000 live male babies and varies considerably in severity. The position of the urethral meatus can be classified as anterior or distal (glandular, coronal, or subcoronal; 60-65% of cases), middle (midpenile; 20-30% of cases), or posterior or… Read more about this study
- Who is it for?
- Ages 6 months to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- Uroflowmetry
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 May 2023
- How long will I take part?
- 1 Year
- 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 6 months to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non probability sample size) with Confidence Level 90 % , Population Size 10000 , Margin of Error 8 % with expected size of 105 patients starting from 01/04/2021 to 1/04/2022.
Who may be able to join
- More than six months after last hypospadias repair.
- Toilet trained children.
- Patients less than 18 years old.
- Successful repair of hypospadias with HOSE score more than 10 decided by one of the experts in pediatric urology.
Who cannot join
- Patient not welling to participate in our study.
- Within six months of last hypospadias repair.
- Patient had urethral intervention within 3 months.
- Children with any associated neurological or urological abnormality related to the bladder, which could potentially affect flow pattern.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, 11754
Mohamad A Ezzat, Resident, +201028511082, mohamed.20134296@med.au.edu.eg
About this study
Hypospadias is a common anomaly of the male genitalia affecting 0.4-8.2 of 1000 live male babies and varies considerably in severity. The position of the urethral meatus can be classified as anterior or distal (glandular, coronal, or subcoronal; 60-65% of cases), middle (midpenile; 20-30% of cases), or posterior or proximal (posterior penile, penoscrotal, scrotal, or perineal; 10-15% of cases). The subcoronal position is the most common. Most cases are mild and surgical correction is undertaken mostly for cosmetic reasons at the request of the parents or on advice of the pediatrician or surgeon.
Functional success of hypospadias repair depends on the creation of a uniform and adequate caliber urethra up to the meatus. Accordingly, meatal stenosis and urethral stricture are the important complications of surgery, others include urethrocutaneous fistula, diverticula, skin flap necrosis and persistent chordee. Although functional assessment of the repair is possible by observation of the urinary stream and voiding cystourethrography, uroflowmetry is considered to be a more objective tool, especially for the detection of a subclinical urethral stricture. Reports of the results of hypospadias surgery commonly focus on the cosmetic results and incidence of obvious complications, as urethrocutaneous fistulas, and symptomatic urethral Strictures. Few have emphasized the role of uroflowmetry in the postoperative evaluation of children with hypospadias to detect asymptomatic strictures and, despite the simplicity and non-invasive nature of this test, it has not become standard or widely accepted.
We evaluate AUUH experience by use of 'hypospadias objective scoring evaluation' HOSE and uroflowmetry after hypospadias repair. The HOSE is a validated scoring system that incorporates the evaluation of meatal location and shape, urinary stream, straightness of erection, presence and complexity of urethral fistula. The minimum total score is 5, and the maximum total score is 16. The point score is graded as either acceptable or not.
- Conditions
- Hypospadias
- Being tested
- Uroflowmetry
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroflowmetryOther
Diagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.
Measured: Within 5 years post operative
Number of patients in each Type of the curve of the uroflowmetry.
Number of patients in each Type of the curve of the uroflowmetry.
Measured: Within 5 years postoperative
Finding correlation between the results of uroflowmetry and HOSE score.
Finding correlation between the results of uroflowmetry and HOSE score.
Measured: Within 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 105 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mohammad Alaa Ezzat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Alaa Ezzat, Assiut University
- Investigators
- Hisham M Hammoda, Professor, Study director, Assiut UniversityAmr H Abo fadan, Lecturer, Study director, Assiut UniversityMahmoud F Ali, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032222
- Sponsor's protocol ID
- Hypospadias repair evaluation
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Olsen LH, Grothe I, Rawashdeh YF, Jorgensen TM. Urinary flow patterns in infants with distal hypospadias. J Pediatr Urol. 2011 Aug;7(4):428-32. doi: 10.1016/j.jpurol.2010.05.013. Epub 2010 Jul 2.
PubMed 20598640Page RE, Akin Y. Assessment of urine flow in hypospadias. Br J Plast Surg. 1978 Oct;31(4):313-6. doi: 10.1016/s0007-1226(78)90117-0. No abstract available.
PubMed 152135Toguri AG, Uchida T, Bee DE. Pediatric uroflow rate nomograms. J Urol. 1982 Apr;127(4):727-31. doi: 10.1016/s0022-5347(17)54018-5. No abstract available.
PubMed 7069841Gonzalez R, Ludwikowski BM. Importance of urinary flow studies after hypospadias repair: a systematic review. Int J Urol. 2011 Nov;18(11):757-61. doi: 10.1111/j.1442-2042.2011.02839.x. Epub 2011 Aug 30.
PubMed 21883491Kaya C, Kucuk E, Ilktac A, Ozturk M, Karaman MI. Value of urinary flow patterns in the follow-up of children who underwent Snodgrass operation. Urol Int. 2007;78(3):245-8. doi: 10.1159/000099346.
PubMed 17406135Holmdahl G, Karstrom L, Abrahamsson K, Doroszkiewicz M, Sillen U. Hypospadias repair with tubularized incised plate. Is uroflowmetry necessary postoperatively? J Pediatr Urol. 2006 Aug;2(4):304-7. doi: 10.1016/j.jpurol.2005.11.018. Epub 2006 Mar 30.
PubMed 18947626Garignon C, Chamond C, Lefebure B, Halim Y, Mitrofanoff P, Liard A. [Uroflowmetric functional evaluation of modified Duplay procedure in hypospadias surgery]. Prog Urol. 2004 Dec;14(6):1199-202; discussion 1202. French.
PubMed 15751419Jayanthi VR, McLorie GA, Khoury AE, Churchill BM. Functional characteristics of the reconstructed neourethra after island flap urethroplasty. J Urol. 1995 May;153(5):1657-9.
PubMed 7715002Scarpa MG, Castagnetti M, Berrettini A, Rigamonti W, Musi L. Urinary function after Snodgrass repair of distal hypospadias: comparison with the Mathieu repair. Pediatr Surg Int. 2010 May;26(5):519-22. doi: 10.1007/s00383-010-2569-6. Epub 2010 Feb 19.
PubMed 20169443Wolffenbuttel KP, Wondergem N, Hoefnagels JJ, Dieleman GC, Pel JJ, Passchier BT, de Jong BW, van Dijk W, Kok DJ. Abnormal urine flow in boys with distal hypospadias before and after correction. J Urol. 2006 Oct;176(4 Pt 2):1733-6; discussion 1736-7. doi: 10.1016/S0022-5347(06)00614-8.
PubMed 16945635Tuygun C, Bakirtas H, Gucuk A, Cakici H, Imamoglu A. Uroflow findings in older boys with tubularized incised-plate urethroplasty. Urol Int. 2009;82(1):71-6. doi: 10.1159/000176029. Epub 2009 Jan 20.
PubMed 19172101Eassa W, Brzezinski A, Capolicchio JP, Jednak R, El-Sherbiny M. How do asymptomatic toilet-trained children void following tubularized incised-plate hypospadias repair? Can Urol Assoc J. 2012 Aug;6(4):238-42. doi: 10.5489/cuaj.12029.
PubMed 23093529
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
- ClinicalTrials.gov ID
- NCT05032222
- Acronym / sponsor ID
- Hypospadias repair evaluation
- Conditions
- Hypospadias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mohammad Alaa EzzatUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 2 Sep 2021 (actual)
- 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 anomaly of the male genitalia affecting 0.4-8.2 of 1000 live male babies and varies considerably in severity. The position of the urethral meatus can be classified as anterior or distal (glandular, coronal, or subcoronal; 60-65% of cases), middle (midpenile; 20-30% of cases), or posterior or proximal (posterior penile, penoscrotal, scrotal, or perineal; 10-15% of cases). The subcoronal position is the most common. Most cases are mild and surgical correction is undertaken mostly for cosmetic reasons at the request of the parents or on advice of the pediatrician or surgeon.
Functional success of hypospadias repair depends on the creation of a uniform and adequate caliber urethra up to the meatus. Accordingly, meatal stenosis and urethral stricture are the important complications of surgery, others include urethrocutaneous fistula, diverticula, skin flap necrosis and persistent chordee. Although functional assessment of the repair is possible by observation of the urinary stream and voiding cystourethrography, uroflowmetry is considered to be a more objective tool, especially for the detection of a subclinical urethral stricture. Reports of the results of hypospadias surgery commonly focus on the cosmetic results and incidence of obvious complications, as urethrocutaneous fistulas, and symptomatic urethral Strictures. Few have emphasized the role of uroflowmetry in the postoperative evaluation of children with hypospadias to detect asymptomatic strictures and, despite the simplicity and non-invasive nature of this test, it has not become standard or widely accepted.
We evaluate AUUH experience by use of 'hypospadias objective scoring evaluation' HOSE and uroflowmetry after hypospadias repair. The HOSE is a validated scoring system that incorporates the evaluation of meatal location and shape, urinary stream, straightness of erection, presence and complexity of urethral fistula. The minimum total score is 5, and the maximum total score is 16. The point score is graded as either acceptable or not.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non probability sample size) with Confidence Level 90 % , Population Size 10000 , Margin of Error 8 % with expected size of 105 patients starting from 01/04/2021 to 1/04/2022.
Key inclusion criteria (4 listed)
- More than six months after last hypospadias repair.
- Toilet trained children.
- Patients less than 18 years old.
- Successful repair of hypospadias with HOSE score more than 10 decided by one of the experts in pediatric urology.
Key exclusion criteria (4 listed)
- Patient not welling to participate in our study.
- Within six months of last hypospadias repair.
- Patient had urethral intervention within 3 months.
- Children with any associated neurological or urological abnormality related to the bladder, which could potentially affect flow pattern.
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 |
|---|---|---|
| UroflowmetryDiagnostic test | Other | – |
Primary outcome
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.
Time frame: Within 5 years post operative
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.
Number of patients in each Type of the curve of the uroflowmetry.
Time frame: Within 5 years postoperative
Number of patients in each Type of the curve of the uroflowmetry.
Finding correlation between the results of uroflowmetry and HOSE score.
Time frame: Within 5 years postoperative
Finding correlation between the results of uroflowmetry and HOSE score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 20598640Olsen LH, Grothe I, Rawashdeh YF, Jorgensen TM. Urinary flow patterns in infants with distal hypospadias. J Pediatr Urol. 2011 Aug;7(4):428-32. doi: 10.1016/j.jpurol.2010.05.013. Epub 2010 Jul 2.
- Background: PubMed 152135Page RE, Akin Y. Assessment of urine flow in hypospadias. Br J Plast Surg. 1978 Oct;31(4):313-6. doi: 10.1016/s0007-1226(78)90117-0. No abstract available.
- Background: PubMed 7069841Toguri AG, Uchida T, Bee DE. Pediatric uroflow rate nomograms. J Urol. 1982 Apr;127(4):727-31. doi: 10.1016/s0022-5347(17)54018-5. No abstract available.
- Background: PubMed 21883491Gonzalez R, Ludwikowski BM. Importance of urinary flow studies after hypospadias repair: a systematic review. Int J Urol. 2011 Nov;18(11):757-61. doi: 10.1111/j.1442-2042.2011.02839.x. Epub 2011 Aug 30.
- Background: PubMed 17406135Kaya C, Kucuk E, Ilktac A, Ozturk M, Karaman MI. Value of urinary flow patterns in the follow-up of children who underwent Snodgrass operation. Urol Int. 2007;78(3):245-8. doi: 10.1159/000099346.
- Background: PubMed 18947626Holmdahl G, Karstrom L, Abrahamsson K, Doroszkiewicz M, Sillen U. Hypospadias repair with tubularized incised plate. Is uroflowmetry necessary postoperatively? J Pediatr Urol. 2006 Aug;2(4):304-7. doi: 10.1016/j.jpurol.2005.11.018. Epub 2006 Mar 30.
- Background: PubMed 15751419Garignon C, Chamond C, Lefebure B, Halim Y, Mitrofanoff P, Liard A. [Uroflowmetric functional evaluation of modified Duplay procedure in hypospadias surgery]. Prog Urol. 2004 Dec;14(6):1199-202; discussion 1202. French.
- Background: PubMed 7715002Jayanthi VR, McLorie GA, Khoury AE, Churchill BM. Functional characteristics of the reconstructed neourethra after island flap urethroplasty. J Urol. 1995 May;153(5):1657-9.
- Background: PubMed 20169443Scarpa MG, Castagnetti M, Berrettini A, Rigamonti W, Musi L. Urinary function after Snodgrass repair of distal hypospadias: comparison with the Mathieu repair. Pediatr Surg Int. 2010 May;26(5):519-22. doi: 10.1007/s00383-010-2569-6. Epub 2010 Feb 19.
- Background: PubMed 16945635Wolffenbuttel KP, Wondergem N, Hoefnagels JJ, Dieleman GC, Pel JJ, Passchier BT, de Jong BW, van Dijk W, Kok DJ. Abnormal urine flow in boys with distal hypospadias before and after correction. J Urol. 2006 Oct;176(4 Pt 2):1733-6; discussion 1736-7. doi: 10.1016/S0022-5347(06)00614-8.
- Background: PubMed 19172101Tuygun C, Bakirtas H, Gucuk A, Cakici H, Imamoglu A. Uroflow findings in older boys with tubularized incised-plate urethroplasty. Urol Int. 2009;82(1):71-6. doi: 10.1159/000176029. Epub 2009 Jan 20.
- Background: PubMed 23093529Eassa W, Brzezinski A, Capolicchio JP, Jednak R, El-Sherbiny M. How do asymptomatic toilet-trained children void following tubularized incised-plate hypospadias repair? Can Urol Assoc J. 2012 Aug;6(4):238-42. doi: 10.5489/cuaj.12029.
- Individual participant dataSharing planned: Undecided
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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.
Hisham M Hammoda, Professor study director
Assiut University
Amr H Abo fadan, Lecturer study director
Assiut University
Mahmoud F Ali, Lecturer study director
Assiut University
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 Mohammad Alaa Ezzat at 1 site in Egypt.
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 4 inclusion and 4 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 27 Sep 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamad A Ezzat, Resident (+201125035035, mohamed.20134296@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values. (time frame: Within 5 years post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032222, which also lists 12 linked publications.
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 27 Sep 2021.