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NCT Number: NCT02103712

Long Term Outcome of Hypospadias Repair

Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. The opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. Although the most commonly practised corrective operation ( TIP procedure) gives generally good results, recently published evidence points to a possible long term risk of stenosis ( narrowing of the reconstructed urethra). This comparative study will combine clinical assessment with non invasive measurements of urinary flow to assess the functional outcome of a large series of patients who have undergone hypospadias surgery . The study is primarily designed to answer this question : does a modification of the standard operation which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow and a decreased risk of stenosis? This has not been previously studied . The findings of our study could make an important contribution to improvements in the surgical treatment of boys born with hypospadias.

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

3 year–17 year

Sex eligibility

Male

Study type

Observational

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1 Patients with hypospadias who have been treated one of the following two surgical proceduresStandard Tubularised Incised Plate (TIP) operation (Group A) or Tubularised Incised Plate (TIP) procedure incorporating a free graft of preputial skin (in a layer of foreskin) into the urethral reconstruction (Group B ) 2 The study will be confined to primary operations. Patients in whom either of the techniques was used for a secondary or 'redo' procedure will be excluded from the study.

3 The study will be confined to boys over 3 years of age who are potty trained and able to pass urine for the non invasive flow rate test .

Exclusion criteria

  • 1 Patients whose hypospadias was corrected using some technique other than 'standard' or 'grafted' TIP repair.

2 "Redo" cases 3 Boys under 3 years at the time of the study or patients who do not have full bladder control for some other reason.

Treatment and study plan

Qualitative

Other

Primary outcomes

  1. Does a modification of the standard TIP hypospadias operation which incorporates a skin graft into the reconstructed urethra result in improved urinary flow and a (presumed)decrease in the long term risk of stenosis?

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Official study title

Long Term Outcome of Hypospadias Repair: A Comparative Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2014
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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