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NCT Number: NCT06520423

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

9 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Urethral stent tube irrigation

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

Procedure

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

Primary outcomes

  1. Overall complication rate

    Time frame: 12 months

    Probability of overall complications following urethroplasty in adolescent boys with hypospadias.

  2. Specific complication rates

    Time frame: 12 months

    Probability of specific complications following urethroplasty in adolescent boys with hypospadias.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Xing Liu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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