Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias: A Multicenter Randomized Controlled Trial

Xing Liu2 sites in 1 country150 target enrollmentJanuary 2, 2025

ConditionsHypospadias

InterventionsUrinary catheter drainage Urethral stent tube irrigation

Overview

Phase: Not Applicable
Intervention: Urinary catheter drainage
Conditions: Hypospadias
Sponsor: Xing Liu
Enrollment: 150
Locations: 2
Primary Endpoint: Overall complication rate
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This multicenter randomized controlled trial aims to determine whether urethral stent tube irrigation, combined with urinary catheter drainage, prevents postoperative wound infections compared to urinary catheter drainage alone in adolescents with hypospadias.

Detailed Description

Hypospadias is one of the most common genital developmental malformations in pediatric patients, with a prevalence of approximately 0.5%. The primary manifestations of hypospadias include an ectopic urethral opening, penile recurvature, and abnormal distribution of the prepuce. Currently, urethroplasty is the only treatment for hypospadias, with surgery recommended within the first three years of life. However, due to economic, cultural, and social factors, many children miss the optimal age for surgery and require initial or re-repair surgery during puberty. Additionally, some children who underwent hypospadias repair before puberty develop penile recurvature and other complications during adolescence, necessitating reoperation. Physiological changes during puberty, such as penile growth, pubic hair development, increased skin appendages, secretions, and frequency of erections, increase the risk of wound infection and poor healing post-surgery. To address these issues, we placed a stent in the reconstructed urethra of adolescents with hypospadias and performed urethral irrigation postoperatively.

Registry

clinicaltrials.gov

Start Date

January 2, 2025

End Date

April 20, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Xing Liu

Responsible Party

Sponsor Investigator

Principal Investigator

Xing Liu

Professor, Doctor

Children's Hospital of Chongqing Medical University

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with hypospadias and in Tanner stages II-V at the Department of Urology, Affiliated Children's Hospital of Chongqing Medical University.
•Patients and their guardians have been informed about the nature of the study, understand the protocol, can ensure compliance, and have signed an informed consent form.

Exclusion Criteria

•Patients undergoing meatal advancement and glanuloplasty (MAGPI) only.
•Patients undergoing penile recurvature correction only.
•Patients undergoing only urethral fistula formation/urethrostomy.
•Patients with a prostatic utricle.
•Patients with contraindications to the procedure, such as severe cardiac disease, systemic or localized infection, thrombocytopenia, coagulation disorders, congenital immunodeficiencies, or uncontrolled diabetes mellitus.
•Patients already enrolled in or during the follow-up of other clinical studies. Patients who do not wish to participate in this study or demonstrate poor compliance with follow-up requirements.