Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis (DISMUD)

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.

Study Overview

• Status: Withdrawn
• Conditions: Congenital Urogenital Anomaly
• Intervention / Treatment: Diagnostic test: Hematoxylin-eosin and smooth muscle actin markers

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 Type: Observational

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 110231
    • Luis Gabriel Villarraga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.

Description

Inclusion Criteria:

• Male patients scheduled for correction of congenital megaprepuce
• Male patients scheduled for correction of hypospadias
• Male patients scheduled for circumcision for non-medical reasons.

Exclusion Criteria:

• Patients with a history of hypospadias correction.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Congenital Megaprepuce; Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers	Diagnostic test: Hematoxylin-eosin and smooth muscle actin markers; 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.
Hypospadias; Hypospadias Hematoxylin-eosin and smooth muscle actin markers	Diagnostic test: Hematoxylin-eosin and smooth muscle actin markers; 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.
Control; Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers	Diagnostic test: Hematoxylin-eosin and smooth muscle actin markers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in the distribution of the smooth Muscle In Dartos	Smooth Muscle Fibers	1 year
Describe the pattern of smooth muscle in patients with megaprepuce	Smooth Muscle Fibers	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the pattern of smooth muscle in patients with hypospadias	Smooth Muscle Fibers	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio
• Investigators: Principal Investigator: Jose N Fernandez, MD, H

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.
• Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: September 24, 2017
• First Submitted That Met QC Criteria: September 24, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Congenital Abnormalities; Hypospadias; Histology; Congenital megaprepuce
• Additional Relevant MeSH Terms: Congenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities
• Other Study ID Numbers: FM-CIE-0319-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No