Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias

NCT07243457 | Completed DMC

• 2 other identifiers: CHM-UCF-Stent-RCT-2025-01Punjab Health Commission
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Hypospadias is a birth condition in which the urine opening is on the underside of the penis. Surgery (urethroplasty) is the standard treatment. Surgeons sometimes leave a small tube ("stent") inside the new urine passage after surgery, but it is unclear whether using a stent affects the risk of a common complication called a urethrocutaneous fistula (a small leak from the new urethra to the skin). This study will compare two routine surgical approaches for boys 1-12 years old with distal or mid-penile hypospadias who need urethroplasty: (1) surgery with a temporary stent and (2) surgery without a stent. Children will be randomly assigned to one of the two groups. All surgeries will be performed by a consultant pediatric surgeon using a standardized technique, and all children will receive usual postoperative care. Families will return for follow-up at 2, 6, and 12 weeks after surgery. At these visits, the team will check for fistula using a simple saline test and record any other concerns. We aim to learn which approach leads to fewer complications, less discomfort, and fewer additional procedures for children undergoing hypospadias repair.

Conditions

Hypospadias

Keywords

urethroplasty; stent

Outcome Measures

Primary Outcomes (1)

• Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty

  Urethrocutaneous fistula (UCF) will be determined by injecting normal saline under pressure into the terminal neourethra while compressing the penile base; visible saline spillage between two points is counted as positive. Outcome is the proportion of participants with UCF in each arm (stent vs stentless). Assessments occur at routine follow-ups (2, 6, and 12 weeks), with the primary analysis at 12 weeks.

  twelve weeks post operation

Study Arms (2)

Stented Urethroplasty

EXPERIMENTAL

Standardized urethroplasty performed under general anesthesia with a urethral stent (6-8 Fr nasogastric tube, size by age). Repairs in 3 layers (PDS 6/0 for first/second layers; Polyglactin 5/0 for skin). Stent removed on postoperative day 7; discharge thereafter.

Procedure: Stent urethroplasty

Stentless Urethroplasty

ACTIVE COMPARATOR

Same standardized urethroplasty without a stent; discharge on postoperative day 2.

Procedure: Stentless urethroplasty

Interventions

Stent urethroplasty PROCEDURE

Urethroplasty with temporary urethral stent (6-8 Fr nasogastric tube) placed intraoperatively and removed on postoperative day 7. Standardized technique: incision after infiltration with 0.5% lignocaine + adrenaline (1:200,000; 5-7 mg/kg), 3-layer repair (PDS 6/0 for first and second layers-interrupted then continuous; Polyglactin 5/0 interrupted for skin). Routine postoperative antibiotics and analgesia. Applies to Arm(s): Stent Urethroplasty (Group A).

Stented Urethroplasty

Stentless urethroplasty PROCEDURE

Urethroplasty without urethral stent using the same standardized operative technique and peri-operative care; planned discharge on postoperative day 2. Applies to Arm(s): Stentless Urethroplasty (Group B).

Stentless Urethroplasty

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Distal or mid-penile hypospadias planned for urethroplasty
• Parent/guardian provides written informed consent

You may not qualify if:

• \. Planned staged repair

Sponsors & Collaborators

• Children's Hospital and Institute of Child Health, Multan: lead

Study Sites (1)

children Hospital Multan

Multan Khurd, Punjab Province, 60000, Pakistan

Location

Related Publications (2)

• Demirbilek S, Atayurt HF. One-stage hypospadias repair with stent or suprapubic diversion: which is better? J Pediatr Surg. 1997 Dec;32(12):1711-2. doi: 10.1016/s0022-3468(97)90511-x.

  PMID: 9434004 RESULT

• Buson H, Smiley D, Reinberg Y, Gonzalez R. Distal hypospadias repair without stents: is it better? J Urol. 1994 Apr;151(4):1059-60. doi: 10.1016/s0022-5347(17)35180-7.

  PMID: 8126792 RESULT

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

• Saira Shafee, MBBS

  Children's Hospital and Institute of Child Health, Multan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two parallel groups randomized to urethroplasty with stent (Group A) or without stent (Group B); single-center RCT at Children's Hospital Multan.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 21, 2025
• Study Start: May 25, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)