HypospadiasUCFStentRCTNCT07243457
Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias
A study testing Stent urethroplasty and Stentless urethroplasty in people with Hypospadias, run by Children's Hospital and Institute of Child Health, Multan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Stent urethroplasty and Stentless urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 25 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Distal or mid-penile hypospadias planned for urethroplasty
- Parent/guardian provides written informed consent
Who cannot join
- 1. Planned staged repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence Of Urethrocutaneous Fistula Formation In Patients Undergoing Urethroplasty With And Without Stent For Hypospadias
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.
Read the 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
- Being tested
- Stent urethroplasty, Stentless urethroplasty
- Keywords
- urethroplasty, stent
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent urethroplastyProcedure or surgery
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 urethroplastyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stent urethroplasty |
| Stentless Urethroplasty | Active comparator | Same standardized urethroplasty without a stent; discharge on postoperative day 2. Receives: Procedure: Stentless urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: twelve weeks post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 May 2025
- Primary completion20 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups randomized to urethroplasty with stent (Group A) or without stent (Group B); single-center RCT at Children's Hospital Multan.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Saira Shafee, Children's Hospital and Institute of Child Health, Multan
- Investigators
- Saira Shafee, MBBS, Principal investigator, Children's Hospital and Institute of Child Health, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243457
- Sponsor's protocol ID
- CHM-UCF-Stent-RCT-2025-01
- Other IDs
- Punjab Health Commission
- Acronym
- UCFStentRCT
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9434004Buson 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.
PubMed 8126792
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Of Urethrocutaneous Fistula Formation In Patients Undergoing Urethroplasty With And Without Stent For Hypospadias
- ClinicalTrials.gov ID
- NCT07243457
- Acronym / sponsor ID
- UCFStentRCT / CHM-UCF-Stent-RCT-2025-01
- Conditions
- Hypospadias
- Keywords
- urethroplasty, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- 25 May 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups randomized to urethroplasty with stent (Group A) or without stent (Group B); single-center RCT at Children's Hospital Multan.
| Arm | Type | Receives |
|---|---|---|
| Stented Urethroplasty | Experimental | Procedure: Stent urethroplastyStandardized 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. |
| Stentless Urethroplasty | Active comparator | Procedure: Stentless urethroplastySame standardized urethroplasty without a stent; discharge on postoperative day 2. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Distal or mid-penile hypospadias planned for urethroplasty
- Parent/guardian provides written informed consent
Key exclusion criteria (1 listed)
- 1. Planned staged repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent urethroplastyUrethroplasty 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). | Procedure or surgery | Stented Urethroplasty |
| Stentless urethroplastyUrethroplasty 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). | Procedure or surgery | Stentless Urethroplasty |
Primary outcome
Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty
Time frame: twelve weeks post operation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 9434004Demirbilek 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.
- Results publication: PubMed 8126792Buson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saira Shafee, MBBS principal investigator
Children's Hospital and Institute of Child Health, Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent urethroplasty and Stentless urethroplasty in people with Hypospadias, run by Children's Hospital and Institute of Child Health, Multan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty (time frame: twelve weeks post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07243457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.