Clinical Trial

Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.

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Summary
Urethroplasty is considered the gold standard for the treatment of urethral stricture disease, with a success rate of more than 93% in terms of stricture recurrence. The objective of this study is to compare the outcomes of excision and primary anastomosis (EPA) urethroplasty, a transecting urethroplasty technique, and tunica vaginalis graft (TVG) urethroplasty, a non-transecting urethroplasty technique, in patients with bulbar urethral strictures up to 2 cm in length. This will be a randomized controlled trial (RCT) involving 94 patients admitted to Sahiwal Teaching Hospital, Sahiwal. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. Group A patients will undergo excision and primary anastomosis (EPA) urethroplasty, while Group B patients will undergo tunica vaginalis graft (TVG) urethroplasty. Non-probability convenience sampling will be used. A detailed history of urinary symptoms, sexual function, catheterization, instrumentation, urinary tract infection, and trauma will be obtained to determine the cause of the stricture. Demographic information, including name, age, and contact number, will be recorded. Preoperative investigations will include complete blood count, renal function test, liver function test, urine complete examination, ultrasonography of the kidneys, ureters, and bladder with post-void residual volume (PVR), uroflowmetry, and retrograde urethrogram for the diagnosis and measurement of stricture length. Other study parameters will include length of hospital stay and postoperative complications, such as graft failure, wound infection, urinary tract infection, and fistula formation. Data will be collected using a structured proforma and entered into the Statistical Package for the Social Sciences (SPSS) version 26.0 for analysis. For quantitative variables, the mean and standard deviation will be calculated. For qualitative variables, frequencies and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. The chi-square test will be used to assess the association between qualitative variables, while the independent samples t-test will be applied to quantitative variables. A p-value of less than 0.05 will be considered statistically significant. It is anticipated that tunica vaginalis graft (TVG) urethroplasty will provide better outcomes than excision and primary anastomosis (EPA) urethroplasty.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-07 -> 2027-08 2026-08-06
minor Completion pushed: 2027-07 -> 2027-08 2026-08-06
Trial Details
NCT Number NCT07668973
Lead Sponsor Sahiwal medical college sahiwal
Conditions Urethral Stricture, Erectile Dysfunction
Enrollment 94 participants
Start Date 2026-08
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-05