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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urinary catheter drainage | Active Comparator | These patients will undergo urinary catheter drainage for seven days following urethroplasty |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xing Liu, Doctor | Children's Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19155122 | Background | 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. | |
| 19186110 | 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. |
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Apart from the participant's personal information.
6 months
Apart from the participant's personal information.
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| Urinary catheter drainage | Procedure | During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder. |
|
| 12 months |
| 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. | 12 months |
| 5440182 | 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. |
| 23179731 | 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. |
| 11125368 | 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. |
| 14686562 | 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. |
| 7869477 | 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. |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |