Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias

NCT ID: NCT07243457

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-25
• Study Completion Date: 2025-09-30

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.

Detailed Description

Objective. To compare the incidence of urethrocutaneous fistula (UCF) after hypospadias urethroplasty performed with versus without a postoperative urethral stent. Primary endpoint: UCF at 12 weeks post-operation, defined by saline injection into the neourethra with proximal compression; visible saline spillage between two points is counted as positive.

Design and Setting. Single-center, randomized controlled trial at the Department of Pediatric Surgery, Children's Hospital Multan. Duration: 6 months from synopsis approval. Target sample size: 110 (power 80%, two-proportion test; expected UCF 13.3% with stent vs 33.3% without stent; α=0.05). Allocation by sealed opaque-envelope lottery to two parallel groups.

Participants. Inclusion: boys aged 1-12 years with distal or mid-penile hypospadias scheduled for urethroplasty. Exclusion: prior failed urethroplasty or planned staged repair. Written informed consent from parents/guardians.

Interventions.

Group A (Stent urethroplasty): Standardized urethroplasty with a 6-8 Fr nasogastric tube as temporary stent (size by age). Stent removed on postoperative day 7; discharge thereafter.

Group B (Stentless urethroplasty): Standardized urethroplasty without stent; discharge on postoperative day 2.

All operations under general anesthesia by a consultant pediatric surgeon. Hemostasis with lignocaine 0.5% + adrenaline 1:200,000 (5-7 mg/kg). Repairs in 3 layers (PDS 6/0 first & second layers-interrupted then continuous; skin closure with Polyglactin 5/0 interrupted). Standard postoperative antibiotics and analgesia for both groups.

Follow-up and Assessments. Clinic visits at 2, 6, and 12 weeks. Primary outcome (UCF) assessed with the protocolized saline test; secondary observations include general recovery and any additional interventions. Data captured on a predefined proforma.

Statistical Analysis. Data analyzed in SPSS v23. Normality of numeric variables (e.g., age) by Shapiro-Wilk; age summarized as mean±SD. Categorical variables (site of hypospadias; UCF yes/no) as frequencies/percentages. Primary comparison between groups by chi-square (p<0.05 significant). Stratified analyses by age and hypospadias location with post-stratification chi-square (p<0.05).

Rationale and Significance. Prior comparative studies report differing UCF rates with versus without stents; this trial is designed to provide clearer evidence to guide routine practice, potentially reducing complications, discomfort, and healthcare costs for children undergoing hypospadias repair.

Conditions

Hypospadias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stented Urethroplasty

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.

Group Type: EXPERIMENTAL

Stent urethroplasty

Intervention Type: 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).

Stentless Urethroplasty

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

Group Type: ACTIVE_COMPARATOR

Stentless urethroplasty

Intervention Type: 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).

Interventions

Stent urethroplasty

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).

Intervention Type: PROCEDURE

Stentless urethroplasty

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Distal or mid-penile hypospadias planned for urethroplasty

2. Parent/guardian provides written informed consent

Exclusion Criteria

1. Planned staged repair

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital and Institute of Child Health, Multan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Saira Shafee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saira Shafee, MBBS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Institute of Child Health, Multan

Locations

children Hospital Multan

Multan Khurd, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

PMID: 9434004 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8126792 (View on PubMed)

Other Identifiers

Punjab Health Commission

Identifier Type: OTHER

Identifier Source: secondary_id

CHM-UCF-Stent-RCT-2025-01

Identifier Type: -

Identifier Source: org_study_id