Urethral stent tube irrigation: During urethroplasty, a Fr3 ureteral catheter will be placed in the reconstructed urethra, with the proximal end extending approximately 2 cm beyond the urethral wound. The distal end will connect to an F6 single-lumen ureter and a urinary bag. On the second postoperative day, the urethra will be irrigated with 5 ml of saline twice daily. This irrigation routine will continue until the catheter is removed.
Urinary catheter drainage: During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.
Study 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.
Eligibility
Sex
MALE
Min age
9 Years
Max age
18 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall complication rate — 12 months Probability of overall complications following urethroplasty in adolescent boys with hypospadias.
Specific complication rates — 12 months Probability of specific complications following urethroplasty in adolescent boys with hypospadias.
Trial sites (1)
Facility
City
Region
Status
Children's Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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