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

January 19, 2026 updated by: Xing Liu

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400000
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Urinary catheter drainage
These patients will undergo urinary catheter drainage for seven days following urethroplasty
Procedure: Urinary catheter drainage
During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.
Experimental: 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
Procedure: Urinary catheter drainage
During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complication rate
Time Frame: 12 months
Probability of overall complications following urethroplasty in adolescent boys with hypospadias.
12 months
Specific complication rates
Time Frame: 12 months
Probability of specific complications following urethroplasty in adolescent boys with hypospadias.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary function
Time Frame: 12 months
Urinary function was evaluated using non-validated questions addressing urinary stream, urinary power, the presence of post-void dribbling, and straining during voiding. Urinary function outcomes were assessed using patient-reported categorical and ordinal measures (urinary stream pattern, urinary power, post-void dribbling, and straining), rather than a composite scoring scale; therefore, no minimum or maximum scale values apply. For ordinal outcomes, higher categories indicate worse urinary symptoms.
12 months
Cosmetic outcomes
Time Frame: 12 months
Cosmetic outcomes were assessed using the Pediatric Penile Perception Score (PPPS), a 4-point ordinal scale ranging from 1 (very dissatisfied) to 4 (very satisfied), with higher scores indicating better cosmetic outcomes.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xing Liu

Investigators

  • Study Director: Xing Liu, Doctor, Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

March 12, 2026

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Apart from the participant's personal information.

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Apart from the participant's personal information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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