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

Not Applicable

Active, not recruiting

• Conditions: Hypospadias
• Interventions: Procedure: Urethral stent tube irrigation; Procedure: Urinary catheter drainage

• Registration Number: NCT06520423
• Lead Sponsor: Xing Liu

Brief Summary

This prospective, cluster-randomized, crossover, two-arm controlled clinical 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.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-21
• Study First Posted: 2024-07-25
• Study Start: 2024-08-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-08-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 160

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 urethrostomy only.
4. Patients with contraindications to the procedure, such as severe cardiac disease, systemic or localized infection, thrombocytopenia, coagulation disorders, congenital immunodeficiencies, or uncontrolled diabetes mellitus.
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Urethral stent tube irrigation (combined with urinary catheter drainage)	Urethral stent tube irrigation	These patients will undergo urinary catheter drainage (combined with urinary catheter drainage) for seven days following urethroplasty
Urethral stent tube irrigation (combined with urinary catheter drainage)	Urinary catheter drainage	These patients will undergo urinary catheter drainage (combined with urinary catheter drainage) for seven days following urethroplasty
Urinary catheter drainage	Urinary catheter drainage	These patients will undergo urinary catheter drainage for seven days following urethroplasty

Primary Outcome Measures

Name	Time	Method
Postoperative complication rate	6 months	Probability of complications after urethroplasty in adolescent children with hypospadias

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction scores regarding the treatment outcomes	6 months	Patient satisfaction with treatment outcomes was assessed using a scale from 0 to 3. A score of 0 represented no postoperative complications, 1 indicated symptoms of malaise with subsequent improvement, 2 signified postoperative complications with minimal disruption to daily life, and 3 denoted significant postoperative complications with considerable disruption to daily life.
Bacterial culture types	7 days	Collect urethral washings from each douche, perform bacterial cultures, and document the bacterial species identified.
Colony number	7 days	Collect urethral washings from each douche, perform bacterial cultures, and record the colony count.
Patient satisfaction scores regarding the treatment process	7 days	Patient satisfaction with the treatment process was assessed using a scale from 0 to 3. A score of 0 indicated no discomfort during treatment, 1 indicated occasional discomfort, 2 indicated that the treatment was mildly uncomfortable but tolerable, and 3 indicated that the treatment was uncomfortable and intolerable.

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China