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

NCT06520423 | Active Not Recruiting DMC

• 1 other identifier: 2024258
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (2)

• Overall complication rate

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

  12 months

• Specific complication rates

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

  12 months

Secondary Outcomes (2)

• Urinary function

  12 months

• Cosmetic outcomes

  12 months

Study Arms (2)

Urinary catheter drainage

ACTIVE COMPARATOR

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

Procedure: Urinary catheter drainage

Urethral stent tube irrigation (combined with urinary catheter drainage)

EXPERIMENTAL

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

Procedure: Urethral stent tube irrigation; Procedure: Urinary catheter drainage

Interventions

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.

Urethral stent tube irrigation (combined with urinary catheter drainage)

Urinary catheter drainage 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); Urinary catheter drainage

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xing Liu: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (7)

• Lund L, Engebjerg MC, Pedersen L, Ehrenstein V, Norgaard M, Sorensen HT. Prevalence of hypospadias in Danish boys: a longitudinal study, 1977-2005. Eur Urol. 2009 May;55(5):1022-6. doi: 10.1016/j.eururo.2009.01.005. Epub 2009 Jan 13.

  PMID: 19155122 BACKGROUND

• Weber DM, Schonbucher VB, Gobet R, Gerber A, Landolt MA. Is there an ideal age for hypospadias repair? A pilot study. J Pediatr Urol. 2009 Oct;5(5):345-50. doi: 10.1016/j.jpurol.2008.12.008. Epub 2009 Jan 30.

  PMID: 19186110 BACKGROUND

• Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in boys. Arch Dis Child. 1970 Feb;45(239):13-23. doi: 10.1136/adc.45.239.13.

  PMID: 5440182 BACKGROUND

• Zheng DC, Wang H, Lu MJ, Chen Q, Chen YB, Ren XM, Yao HJ, Xu MX, Zhang K, Cai ZK, Wang Z. A comparative study of the use of a transverse preputial island flap (the Duckett technique) to treat primary and secondary hypospadias in older Chinese patients with severe chordee. World J Urol. 2013 Aug;31(4):965-9. doi: 10.1007/s00345-012-0990-2. Epub 2012 Nov 23.

  PMID: 23179731 BACKGROUND

• Hensle TW, Tennenbaum SY, Reiley EA, Pollard J. Hypospadias repair in adults: adventures and misadventures. J Urol. 2001 Jan;165(1):77-9. doi: 10.1097/00005392-200101000-00019.

  PMID: 11125368 BACKGROUND

• Cakmak M, Caglayan F, Kilic D, Kaygusuz S, Cakmak A, Ulusoy S, Ozlu N, Ozluk O. Efficacy of povidone-iodine in preputial antisepsis. Int J Clin Pract. 2003 Nov;57(9):752-4.

  PMID: 14686562 BACKGROUND

• Li LC, Zhang X, Zhou SW, Zhou XC, Yang WM, Zhang YS. Experience with repair of hypospadias using bladder mucosa in adolescents and adults. J Urol. 1995 Apr;153(4):1117-9.

  PMID: 7869477 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xing Liu, Doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Doctor

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 25, 2024
• Study Start: January 2, 2025
• Primary Completion: March 12, 2026
• Study Completion: April 20, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months
• Access Criteria: Apart from the participant's personal information.

Locations

CN (1)