Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis

Withdrawn

• Conditions: Congenital Urogenital Anomaly
• Interventions: Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

• Registration Number: NCT03295175
• Lead Sponsor: Hospital Universitario San Ignacio

Brief 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. 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 Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2017-09-24
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-27
• Status Verified: 2024-03
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypospadias	Hematoxylin-eosin and smooth muscle actin markers	Hypospadias Hematoxylin-eosin and smooth muscle actin markers
Congenital Megaprepuce	Hematoxylin-eosin and smooth muscle actin markers	Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers
Control	Hematoxylin-eosin and smooth muscle actin markers	Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers

Primary Outcome Measures

Name	Time	Method
Differences in the distribution of the smooth Muscle In Dartos	1 year	Smooth Muscle Fibers
Describe the pattern of smooth muscle in patients with megaprepuce	1 year	Smooth Muscle Fibers

Secondary Outcome Measures

Name	Time	Method
Describe the pattern of smooth muscle in patients with hypospadias	1 year	Smooth Muscle Fibers

Trial Locations

Locations (1)

Luis Gabriel Villarraga; 🇨🇴 Bogotá, Colombia