Long Term Outcome of Hypospadias Repair

NCT02103712 | Completed

• 1 other identifier: UR12/10496
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypospadias

Outcome Measures

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?

  1 year

Study Arms (1)

Hypospadias

Other: Qualitative

Interventions

Qualitative OTHER

Hypospadias

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypospadias

You may qualify if:

• \- 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.
• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Hypospadias

Interventions

Evaluation Studies as Topic

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: April 4, 2014
• Study Start: October 1, 2012
• Primary Completion: September 30, 2013
• Study Completion: September 30, 2013
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

GB (1)