Hypospadias
Conditions
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.
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.
Interventions
PROCEDUREUrethral stent tube irrigation
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.
PROCEDUREUrinary catheter drainage
During urethroplasty, intraurethral retention of urethral catheters is used to drain urine from the bladder.
Sponsors
Xing Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
9 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with hypospadias and in Tanner stages II-V at the Department of Urology, Affiliated Children's Hospital of Chongqing Medical University. 2. 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
1. Patients undergoing meatal advancement and glanuloplasty (MAGPI) only. 2. Patients undergoing penile recurvature correction only. 3. Patients undergoing only urethral fistula formation/urethrostomy. 4. Patients with a prostatic utricle. 5. Patients with contraindications to the procedure, such as severe cardiac disease, systemic or localized infection, thrombocytopenia, coagulation disorders, congenital immunodeficiencies, or uncontrolled diabetes mellitus. 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall complication rate | 12 months | Probability of overall complications following urethroplasty in adolescent boys with hypospadias. |
| Specific complication rates | 12 months | Probability of specific complications following urethroplasty in adolescent boys with hypospadias. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary function | 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. |
| Cosmetic outcomes | 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. |
Countries
China
Contacts
STUDY_DIRECTORXing Liu, Doctor
Children's Hospital of Chongqing Medical University
Outcome results
None listed