<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03295175</url>
  </required_header>
  <id_info>
    <org_study_id>FM-CIE-0319-17</org_study_id>
    <nct_id>NCT03295175</nct_id>
  </id_info>
  <brief_title>Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis</brief_title>
  <acronym>DISMUD</acronym>
  <official_title>Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario San Ignacio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario San Ignacio</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation&#xD;
      that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the&#xD;
      appearance of the penis. A redundant and enlarged foreskin is the main feature of this&#xD;
      entity.This congenital anomaly is difficult to diagnose and may have association with other&#xD;
      pathologies such as buried penis.&#xD;
&#xD;
      Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows&#xD;
      that patients with this pathology and hypospadias present mostly defects in the muscle&#xD;
      dartos. The investigators do not know the physiological bases of the megaprepuce, neither the&#xD;
      clinical and aesthetics implications of this abnormal tissue for the patient, and how this&#xD;
      affects the postoperative evolution. With the present study the investigators intended to&#xD;
      answer these questions and to open paths for future research in this area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After informed consent, patients will be labeled with a research record number other than the&#xD;
      identity document or the number of the attention. The urologist who perform the correction of&#xD;
      the megaprepuce, will take a segment of the dartos and send it for histopathological&#xD;
      analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the&#xD;
      research record number. Same procedure will be performed with the controls and hypospadias&#xD;
      group. Only the principal investigator will know the assignment of medical record and their&#xD;
      respective group (congenital megaprepuce, hypospadias or controls). The samples will be sent&#xD;
      to pathology without any clinical data, and they will be analyzed by two pathologists, both&#xD;
      blind.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Differences in the distribution of the smooth Muscle In Dartos</measure>
    <time_frame>1 year</time_frame>
    <description>Smooth Muscle Fibers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Describe the pattern of smooth muscle in patients with megaprepuce</measure>
    <time_frame>1 year</time_frame>
    <description>Smooth Muscle Fibers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe the pattern of smooth muscle in patients with hypospadias</measure>
    <time_frame>1 year</time_frame>
    <description>Smooth Muscle Fibers</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Congenital Urogenital Anomaly</condition>
  <arm_group>
    <arm_group_label>Congenital Megaprepuce</arm_group_label>
    <description>Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypospadias</arm_group_label>
    <description>Hypospadias Hematoxylin-eosin and smooth muscle actin markers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hematoxylin-eosin and smooth muscle actin markers</intervention_name>
    <description>The foreskin arrives oriented in a single piece in formol to the unit of pathology, and in the pathology unit, they must:&#xD;
Measure the length, width and thickness of the specimen. The specimen should include skin and mucosa with the underlying areolar tissue.&#xD;
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.</description>
    <arm_group_label>Congenital Megaprepuce</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Hypospadias</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical&#xD;
        correction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients scheduled for correction of congenital megaprepuce&#xD;
&#xD;
          -  Male patients scheduled for correction of hypospadias&#xD;
&#xD;
          -  Male patients scheduled for circumcision for non-medical reasons.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of hypospadias correction.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose N Fernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>H</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luis G Villarraga, MD</last_name>
    <phone>573114741627</phone>
    <email>luisga.villa@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jose N Fernandez, MD</last_name>
    <phone>57 314 3352500</phone>
    <email>nicolasfernandezb@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Luis Gabriel Villarraga</name>
      <address>
        <city>Bogotá</city>
        <zip>110231</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Fernandez, MD</last_name>
      <phone>5946161</phone>
      <email>nicolasfernandezb@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jaime Perez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas Fernandez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luis G Villarraga, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eugenio Meek, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maddy Mejia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>21527191</PMID>
  </results_reference>
  <results_reference>
    <citation>Summerton 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.</citation>
    <PMID>10971284</PMID>
  </results_reference>
  <results_reference>
    <citation>Rod 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.</citation>
    <PMID>23116700</PMID>
  </results_reference>
  <results_reference>
    <citation>Alexander 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.</citation>
    <PMID>20713233</PMID>
  </results_reference>
  <results_reference>
    <citation>Borsellino 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.</citation>
    <PMID>17572214</PMID>
  </results_reference>
  <results_reference>
    <citation>Spinoit 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.</citation>
    <PMID>25444989</PMID>
  </results_reference>
  <results_reference>
    <citation>Cimador 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.</citation>
    <PMID>25850928</PMID>
  </results_reference>
  <results_reference>
    <citation>Maizels 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.</citation>
    <PMID>2873259</PMID>
  </results_reference>
  <results_reference>
    <citation>Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.</citation>
    <PMID>836989</PMID>
  </results_reference>
  <results_reference>
    <citation>Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.</citation>
    <PMID>10631746</PMID>
  </results_reference>
  <results_reference>
    <citation>Hadidi 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.</citation>
    <PMID>24528990</PMID>
  </results_reference>
  <results_reference>
    <citation>Baskin 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.</citation>
    <PMID>11713004</PMID>
  </results_reference>
  <results_reference>
    <citation>Baskin 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.</citation>
    <PMID>16516617</PMID>
  </results_reference>
  <results_reference>
    <citation>Fernandez 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.</citation>
    <PMID>27267992</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Congenital Abnormalities</keyword>
  <keyword>Hypospadias</keyword>
  <keyword>Congenital megaprepuce</keyword>
  <keyword>Histology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urogenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295175
org study id: FM-CIE-0319-17
nct id: NCT03295175
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Differences in the distribution of the smooth Muscle In Dartos
time frame: 1 year
description: Smooth Muscle Fibers
measure: Describe the pattern of smooth muscle in patients with megaprepuce
time frame: 1 year
description: Smooth Muscle Fibers
measure: Describe the pattern of smooth muscle in patients with hypospadias
time frame: 1 year
description: Smooth Muscle Fibers
arm group label: Congenital Megaprepuce
description: Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers
arm group label: Hypospadias
description: Hypospadias Hematoxylin-eosin and smooth muscle actin markers
arm group label: Control
description: Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers
intervention type: Diagnostic Test
intervention name: Hematoxylin-eosin and smooth muscle actin markers
description: 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.
arm group label: Congenital Megaprepuce
arm group label: Control
arm group label: Hypospadias
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 1 Month
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose N Fernandez, MD
role: Principal Investigator
affiliation: H
last name: Luis G Villarraga, MD
phone: 573114741627
email: luisga.villa@gmail.com
last name: Jose N Fernandez, MD
phone: 57 314 3352500
email: nicolasfernandezb@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Colombia
citation: 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.
PMID: 21527191
citation: Summerton 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.
PMID: 10971284
citation: Rod 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.
PMID: 23116700
citation: Alexander 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.
PMID: 20713233
citation: Borsellino 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.
PMID: 17572214
citation: Spinoit 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.
PMID: 25444989
citation: Cimador 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.
PMID: 25850928
citation: Maizels 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.
PMID: 2873259
citation: Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.
PMID: 836989
citation: Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.
PMID: 10631746
citation: Hadidi 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.
PMID: 24528990
citation: Baskin 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.
PMID: 11713004
citation: Baskin 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.
PMID: 16516617
citation: Fernandez 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.
PMID: 27267992
responsible party type: Sponsor
mesh term: Urogenital Abnormalities
sharing ipd: No