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Clinical Trials/NCT07421271
NCT07421271
Completed
Not Applicable

Evaluation of the Method and Duration of Urinary Diversion in the Management of Distal Penile Hypospadias Following Surgical Repair.

Ain Shams University1 site in 1 country86 target enrollmentStarted: April 10, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
Decreased rate of fistula occurrence

Overview

Brief Summary

This study aims to conduct a head-to-head comparison to determine the optimal method and duration of urinary diversion following distal penile hypospadias repair. Specifically, it will evaluate whether urethral diversion alone or a combination of urethral and suprapubic diversions provides better outcomes, and whether a postoperative duration of one week or two weeks is more effective.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
6 Months to 18 Years (Child, Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with Distal Hypospadias (Glanular, Coronal, Subcoronal)
  • Patients have Adequate ventral penile skin mobility

Exclusion Criteria

  • Patients with Crippled hypospadias.
  • Patients with Proximal hypospadias.
  • Patients with Hypoplastic urethra.
  • Patients with Neurogenic bladder

Arms & Interventions

Patient who will be left with urethral catheter for 2 weeks.

Active Comparator

Intervention: Application of urethral catheter alone for 2 weeks. (Procedure)

Patients who will be left with urethral stent and suprapubic catheter for 1 week

Active Comparator

Intervention: Application of urethral stent and suprapubic catheter for 1 week (Procedure)

Patients who will be left with urethral catheter alone for 1 week.

Active Comparator

Intervention: Application of urethral catheter alone for 1 week. (Procedure)

Patients who will be left with urethral stent and suprapubic catheter for 2 weeks

Active Comparator

Intervention: Application of urethral stent and suprapubic catheter for 2 weeks (Procedure)

Outcomes

Primary Outcomes

Decreased rate of fistula occurrence

Time Frame: 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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