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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2026-04-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into one of two intervention arms. A computer-generated randomization sequence-created by staff not involved in trial execution or analysis-will ensure allocation concealment. Assignments will be sealed in sequentially numbered, opaque envelopes held by a clinician independent of the study team.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Urinary catheter drainage

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

Group Type ACTIVE_COMPARATOR

Urinary catheter drainage

Intervention Type PROCEDURE

During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.

Urethral stent tube irrigation (combined with urinary catheter drainage)

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

Group Type EXPERIMENTAL

Urethral stent tube irrigation

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.

Interventions

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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.

Intervention Type PROCEDURE

Urinary catheter drainage

During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No