Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias

Xing Liu

Status: Active, not recruiting

Conditions: Hypospadias

Treatments: Procedure: Urinary catheter drainage; Procedure: Urethral stent tube irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06520423

2024258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with hypospadias and in Tanner stages II-V at the Department of Urology, Affiliated Children's Hospital of Chongqing Medical University.
2. 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

1. Patients undergoing meatal advancement and glanuloplasty (MAGPI) only.
2. Patients undergoing penile recurvature correction only.
3. Patients undergoing only urethral fistula formation/urethrostomy.
4. Patients with a prostatic utricle.
5. Patients with contraindications to the procedure, such as severe cardiac disease, systemic or localized infection, thrombocytopenia, coagulation disorders, congenital immunodeficiencies, or uncontrolled diabetes mellitus.
6. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Urinary catheter drainage

Active Comparator group

Description:

These patients will undergo urinary catheter drainage for seven days following urethroplasty

Treatment:

Procedure: Urinary catheter drainage

Urethral stent tube irrigation (combined with urinary catheter drainage)

Experimental group

Description:

These patients will undergo urinary catheter drainage (combined with urinary catheter drainage) for seven days following urethroplasty

Treatment:

Procedure: Urethral stent tube irrigation

Procedure: Urinary catheter drainage