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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
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.
During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Overall complication rate
Probability of overall complications following urethroplasty in adolescent boys with hypospadias.
Time frame: 12 months
Specific complication rates
Probability of specific complications following urethroplasty in adolescent boys with hypospadias.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
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