Congenital Urogenital AnomalyDISMUDNCT03295175
Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis
An observational study of Congenital Urogenital Anomaly, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. Read more about this study
- Who is it for?
- Ages 1 month to 10 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Urogenital Anomaly
- What is being tested?
- Hematoxylin-eosin and smooth muscle actin markers
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 21 Sep 2017to 12 Mar 2024
- How long will I take part?
- 5 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 1 month to 10 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.
Who may be able to join
- Male patients scheduled for correction of congenital megaprepuce
- Male patients scheduled for correction of hypospadias
- Male patients scheduled for circumcision for non-medical reasons.
Who cannot join
- Patients with a history of hypospadias correction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study
Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. A redundant and enlarged foreskin is the main feature of this entity.This congenital anomaly is difficult to diagnose and may have association with other pathologies such as buried penis.
Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows that patients with this pathology and hypospadias present mostly defects in the muscle dartos. The investigators do not know the physiological bases of the megaprepuce, neither the clinical and aesthetics implications of this abnormal tissue for the patient, and how this affects the postoperative evolution. With the present study the investigators intended to answer these questions and to open paths for future research in this area.
Read the detailed description
After informed consent, patients will be labeled with a research record number other than the identity document or the number of the attention. The urologist who perform the correction of the megaprepuce, will take a segment of the dartos and send it for histopathological analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the research record number. Same procedure will be performed with the controls and hypospadias group. Only the principal investigator will know the assignment of medical record and their respective group (congenital megaprepuce, hypospadias or controls). The samples will be sent to pathology without any clinical data, and they will be analyzed by two pathologists, both blind.
- Conditions
- Congenital Urogenital Anomaly
- Being tested
- Hematoxylin-eosin and smooth muscle actin markers
- Keywords
- Congenital Abnormalities, Hypospadias, Congenital megaprepuce, Histology
- Medical subject headings
- Urogenital Abnormalities, Congenital Abnormalities, Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematoxylin-eosin and smooth muscle actin markersDiagnostic test
The foreskin arrives oriented in a single piece in formol to the unit of pathology, and in the pathology unit, they must:
- Measure the length, width and thickness of the specimen. The specimen should include skin and mucosa with the underlying areolar tissue.
- Examine the surfaces of the sample searching lesions, and describe them in size, appearance (warty, papillary, ulcerated), depth of invasion, and distance from the nearest cutting edge, if they are present.
| Study group | Role | What they receive |
|---|---|---|
| Congenital Megaprepuce | Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers Receives: Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers | |
| Hypospadias | Hypospadias Hematoxylin-eosin and smooth muscle actin markers Receives: Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers | |
| Control | Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers Receives: Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the distribution of the smooth Muscle In Dartos
Smooth Muscle Fibers
Measured: 1 year
Describe the pattern of smooth muscle in patients with megaprepuce
Smooth Muscle Fibers
Measured: 1 year
Secondary outcomes (1)
Describe the pattern of smooth muscle in patients with hypospadias
Smooth Muscle Fibers
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 posted27 Sep 2017
- Study start21 Sep 2017
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Why it stopped: The project never started and contact with the main researcher was lost.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Congenital Urogenital AnomalyStudies 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
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose N Fernandez, MD, Principal investigator, H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295175
- Sponsor's protocol ID
- FM-CIE-0319-17
- Acronym
- DISMUD
- Status last verified
- Mar 2024
- First submitted
- 24 Sep 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz E, Vagni R, Apostolo C, Moldes J, Rodriguez H, Ormaechea M, Giuseppucci C, de Badiola F, Bortagaray J, Perea C. Simplified surgical approach to congenital megaprepuce: fixing, unfurling and tailoring revisited. J Urol. 2011 Jun;185(6 Suppl):2487-90. doi: 10.1016/j.juro.2011.01.015. Epub 2011 Apr 27.
PubMed 21527191Summerton DJ, McNally J, Denny AJ, Malone PS. Congenital megaprepuce: an emerging condition--how to recognize and treat it. BJU Int. 2000 Sep;86(4):519-22. doi: 10.1046/j.1464-410x.2000.00509.x.
PubMed 10971284Rod J, Desmonts A, Petit T, Ravasse P. Congenital megaprepuce: a 12-year experience (52 cases) of this specific form of buried penis. J Pediatr Urol. 2013 Dec;9(6 Pt A):784-8. doi: 10.1016/j.jpurol.2012.10.010. Epub 2012 Oct 30.
PubMed 23116700Alexander A, Lorenzo AJ, Salle JL, Rode H. The Ventral V-plasty: a simple procedure for the reconstruction of a congenital megaprepuce. J Pediatr Surg. 2010 Aug;45(8):1741-7. doi: 10.1016/j.jpedsurg.2010.03.033.
PubMed 20713233Borsellino A, Spagnoli A, Vallasciani S, Martini L, Ferro F. Surgical approach to concealed penis: technical refinements and outcome. Urology. 2007 Jun;69(6):1195-8. doi: 10.1016/j.urology.2007.01.065.
PubMed 17572214Spinoit AF, Van Praet C, Groen LA, Van Laecke E, Praet M, Hoebeke P. Congenital penile pathology is associated with abnormal development of the dartos muscle: a prospective study of primary penile surgery at a tertiary referral center. J Urol. 2015 May;193(5):1620-4. doi: 10.1016/j.juro.2014.10.090. Epub 2014 Oct 23.
PubMed 25444989Cimador M, Catalano P, Ortolano R, Giuffre M. The inconspicuous penis in children. Nat Rev Urol. 2015 Apr;12(4):205-15. doi: 10.1038/nrurol.2015.49. Epub 2015 Apr 7.
PubMed 25850928Maizels M, Zaontz M, Donovan J, Bushnick PN, Firlit CF. Surgical correction of the buried penis: description of a classification system and a technique to correct the disorder. J Urol. 1986 Jul;136(1 Pt 2):268-71. doi: 10.1016/s0022-5347(17)44837-3.
PubMed 2873259Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.
PubMed 836989Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.
PubMed 10631746Hadidi AT. Buried penis: classification surgical approach. J Pediatr Surg. 2014 Feb;49(2):374-9. doi: 10.1016/j.jpedsurg.2013.09.066. Epub 2013 Nov 7.
PubMed 24528990Baskin LS, Himes K, Colborn T. Hypospadias and endocrine disruption: is there a connection? Environ Health Perspect. 2001 Nov;109(11):1175-83. doi: 10.1289/ehp.011091175.
PubMed 11713004Baskin LS, Ebbers MB. Hypospadias: anatomy, etiology, and technique. J Pediatr Surg. 2006 Mar;41(3):463-72. doi: 10.1016/j.jpedsurg.2005.11.059.
PubMed 16516617Fernandez N, Lorenzo A, Bagli D, Zarante I. Altitude as a risk factor for the development of hypospadias. Geographical cluster distribution analysis in South America. J Pediatr Urol. 2016 Oct;12(5):307.e1-307.e5. doi: 10.1016/j.jpurol.2016.03.015. Epub 2016 Apr 22.
PubMed 27267992
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study
- ClinicalTrials.gov ID
- NCT03295175
- Acronym / sponsor ID
- DISMUD / FM-CIE-0319-17
- Conditions
- Congenital Urogenital Anomaly
- Keywords
- Congenital Abnormalities, Hypospadias, Congenital megaprepuce, Histology
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The project never started and contact with the main researcher was lost.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 27 Sep 2017 (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.
Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. A redundant and enlarged foreskin is the main feature of this entity.This congenital anomaly is difficult to diagnose and may have association with other pathologies such as buried penis.
Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows that patients with this pathology and hypospadias present mostly defects in the muscle dartos. The investigators do not know the physiological bases of the megaprepuce, neither the clinical and aesthetics implications of this abnormal tissue for the patient, and how this affects the postoperative evolution. With the present study the investigators intended to answer these questions and to open paths for future research in this area.
Detailed description
After informed consent, patients will be labeled with a research record number other than the identity document or the number of the attention. The urologist who perform the correction of the megaprepuce, will take a segment of the dartos and send it for histopathological analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the research record number. Same procedure will be performed with the controls and hypospadias group. Only the principal investigator will know the assignment of medical record and their respective group (congenital megaprepuce, hypospadias or controls). The samples will be sent to pathology without any clinical data, and they will be analyzed by two pathologists, both blind.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Congenital Megaprepuce | – | Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markersCongenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers |
| Hypospadias | – | Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markersHypospadias Hematoxylin-eosin and smooth muscle actin markers |
| Control | – | Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markersCircumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.
Key inclusion criteria (3 listed)
- Male patients scheduled for correction of congenital megaprepuce
- Male patients scheduled for correction of hypospadias
- Male patients scheduled for circumcision for non-medical reasons.
Key exclusion criteria (1 listed)
- Patients with a history of hypospadias correction.
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 |
|---|---|---|
| Hematoxylin-eosin and smooth muscle actin markersThe foreskin arrives oriented in a single piece in formol to the unit of pathology, and in the pathology unit, they must: 1. Measure the length, width and thickness of the specimen. The specimen should include skin and mucosa with the underlying areolar tissue. 2. Examine the surfaces of the sample searching lesions, and describe them in size, appearance (warty, papillary, ulcerated), depth of invasion, and distance from the nearest cutting edge, if they are present. | Diagnostic test | Congenital Megaprepuce, Control, Hypospadias |
Primary outcome
Differences in the distribution of the smooth Muscle In Dartos
Time frame: 1 year
Smooth Muscle Fibers
Describe the pattern of smooth muscle in patients with megaprepuce
Time frame: 1 year
Smooth Muscle Fibers
1 secondary outcome
Describe the pattern of smooth muscle in patients with hypospadias
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 21527191Ruiz E, Vagni R, Apostolo C, Moldes J, Rodriguez H, Ormaechea M, Giuseppucci C, de Badiola F, Bortagaray J, Perea C. Simplified surgical approach to congenital megaprepuce: fixing, unfurling and tailoring revisited. J Urol. 2011 Jun;185(6 Suppl):2487-90. doi: 10.1016/j.juro.2011.01.015. Epub 2011 Apr 27.
- Results publication: PubMed 10971284Summerton DJ, McNally J, Denny AJ, Malone PS. Congenital megaprepuce: an emerging condition--how to recognize and treat it. BJU Int. 2000 Sep;86(4):519-22. doi: 10.1046/j.1464-410x.2000.00509.x.
- Results publication: PubMed 23116700Rod J, Desmonts A, Petit T, Ravasse P. Congenital megaprepuce: a 12-year experience (52 cases) of this specific form of buried penis. J Pediatr Urol. 2013 Dec;9(6 Pt A):784-8. doi: 10.1016/j.jpurol.2012.10.010. Epub 2012 Oct 30.
- Results publication: PubMed 20713233Alexander A, Lorenzo AJ, Salle JL, Rode H. The Ventral V-plasty: a simple procedure for the reconstruction of a congenital megaprepuce. J Pediatr Surg. 2010 Aug;45(8):1741-7. doi: 10.1016/j.jpedsurg.2010.03.033.
- Results publication: PubMed 17572214Borsellino A, Spagnoli A, Vallasciani S, Martini L, Ferro F. Surgical approach to concealed penis: technical refinements and outcome. Urology. 2007 Jun;69(6):1195-8. doi: 10.1016/j.urology.2007.01.065.
- Results publication: PubMed 25444989Spinoit AF, Van Praet C, Groen LA, Van Laecke E, Praet M, Hoebeke P. Congenital penile pathology is associated with abnormal development of the dartos muscle: a prospective study of primary penile surgery at a tertiary referral center. J Urol. 2015 May;193(5):1620-4. doi: 10.1016/j.juro.2014.10.090. Epub 2014 Oct 23.
- Results publication: PubMed 25850928Cimador M, Catalano P, Ortolano R, Giuffre M. The inconspicuous penis in children. Nat Rev Urol. 2015 Apr;12(4):205-15. doi: 10.1038/nrurol.2015.49. Epub 2015 Apr 7.
- Results publication: PubMed 2873259Maizels M, Zaontz M, Donovan J, Bushnick PN, Firlit CF. Surgical correction of the buried penis: description of a classification system and a technique to correct the disorder. J Urol. 1986 Jul;136(1 Pt 2):268-71. doi: 10.1016/s0022-5347(17)44837-3.
- Results publication: PubMed 836989Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.
- Results publication: PubMed 10631746Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.
- Results publication: PubMed 24528990Hadidi AT. Buried penis: classification surgical approach. J Pediatr Surg. 2014 Feb;49(2):374-9. doi: 10.1016/j.jpedsurg.2013.09.066. Epub 2013 Nov 7.
- Results publication: PubMed 11713004Baskin LS, Himes K, Colborn T. Hypospadias and endocrine disruption: is there a connection? Environ Health Perspect. 2001 Nov;109(11):1175-83. doi: 10.1289/ehp.011091175.
- Individual participant dataSharing planned: No
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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.
Jose N Fernandez, MD principal investigator
H
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 Congenital Urogenital Anomaly, run by Hospital Universitario San Ignacio at 1 site in Colombia.
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 1 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: withdrawn, as of the sponsor's last update on 13 Mar 2024. 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 Colombia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Differences in the distribution of the smooth Muscle In Dartos (time frame: 1 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?
On the ClinicalTrials.gov record for NCT03295175, which also lists 14 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 13 Mar 2024.