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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02103712
Other study ID # UR12/10496
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2012
Est. completion date September 30, 2013

Study information

Verified date August 2019
Source The Leeds Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date September 30, 2013
Est. primary completion date September 30, 2013
Accepts healthy volunteers No
Gender Male
Age group 3 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Qualitative


Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Not yet recruiting NCT05569863 - Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence
Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
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Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A
Suspended NCT05708989 - Caudal vs. Pudendal Block in Peds GU Phase 4