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HypospadiasNCT06520423

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

A study testing Urethral stent tube irrigation and Urinary catheter drainage in people with Hypospadias, run by Xing Liu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 18 years, men only
Conditions the study is for
Hypospadias
What is being tested?
Urethral stent tube irrigation and Urinary catheter drainage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
2 Jan 2025to 20 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Hypospadias
Being tested
Urethral stent tube irrigation, Urinary catheter drainage
Medical subject headings
Hypospadias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urethral stent tube irrigationProcedure or surgery

    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 drainageProcedure or surgery

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

Study groups in NCT06520423
Study groupRoleWhat they receive
Urinary catheter drainageActive comparatorThese patients will undergo urinary catheter drainage for seven days following urethroplasty
Receives: Procedure: Urinary catheter drainage
Urethral stent tube irrigation (combined with urinary catheter drainage)ExperimentalThese patients will undergo urinary catheter drainage (combined with urinary catheter drainage) for seven days following urethroplasty
Receives: Procedure: Urethral stent tube irrigation; Procedure: Urinary catheter drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall complication rate

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

    Measured: 12 months

  2. Specific complication rates

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

    Measured: 12 months

Secondary outcomes (2)

  1. Urinary function

    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.

    Measured: 12 months

  2. Cosmetic outcomes

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start2 Jan 2025
  3. Primary completion12 Mar 2026 (estimated)
  4. Study completion20 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06520423
Sponsor's protocol ID
2024258
Status last verified
Jan 2026
First submitted
16 Jul 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Apart from the participant's personal information.

Publications

  • 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.

    PubMed 19155122

  • 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.

    PubMed 19186110

  • 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.

    PubMed 5440182

  • 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.

    PubMed 23179731

  • 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.

    PubMed 11125368

  • 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.

    PubMed 14686562

  • 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.

    PubMed 7869477

Questions about this trial

What is this clinical trial studying?

A study testing Urethral stent tube irrigation and Urinary catheter drainage in people with Hypospadias, run by Xing Liu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall complication rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06520423, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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