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

NCT07668973 | Not Yet Recruiting DMC

• 1 other identifier: 369/IRB
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urethral Stricture; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Stricture Recurrence

  Defined as the presence of a recurrent stricture on retrograde urethrogram (RUG) or the need for any secondary intervention (e.g., dilatation, direct visual internal urethrotomy, or repeat urethroplasty) within 12 months of the initial surgery.

  12 months

Secondary Outcomes (2)

• Maximum Urine Flow Rate (Qmax)

  12 months

• Erectile Dysfunction

  12 months

Study Arms (2)

Excision and Primary Anastomosis Urethroplasty

OTHER

Procedure: Excision and Primary Anastomosis Urethroplasty

Tunica Vaginalis Graft Urethroplasty

OTHER

Procedure: Tunica Vaginalis Graft Urethroplasty

Interventions

Tunica Vaginalis Graft Urethroplasty PROCEDURE

In Tunica Vaginalis Graft Urethroplasty patients, an incision will be made onto the urethra in the ventral mid-line along the stricture length, opening into healthy proximal and distal urethra and stay sutures will be positioned. Tunica vaginalis graft is harvested by making a small vertical or transverse hemiscrotal incision. The dartos fascia is divided to expose the tunica vaginalis. The testis is gently delivered through the incision.The tunica vaginalis graft outlined and harvested. The tunica vaginalis defect is approximated and testis is placed back into the scrotum. The dartos and skin are closed in layers using absorbable sutures. The graft will be laid as a ventral onlay graft onto the opened urethral defect and sutured to the urethral mucosal edges using absorbable sutures. Quilting or anchoring sutures may be placed to reduce graft dead space and enhance take. Ventral urethrotomy is closed over the catheter using absorbable sutures.

Tunica Vaginalis Graft Urethroplasty

Excision and Primary Anastomosis Urethroplasty PROCEDURE

In Excision and Primary anastomosis urethroplasty patients, an incision will be made down onto the urethra at the level of stricture in the ventral midline. Urethra will be divided with scissors proximally and distally until healthy urethra is entered. Stay sutures will be placed. The scarred urethra will be excised, and the healthy proximal urethral segment will be spatulated dorsally so that it accommodates a 30Fr bougie and the distal urethra will then be spatulated ventrally. The anastomosis will be done using interrupted sutures of 4-0 polydioxanone (PDS).

Excision and Primary Anastomosis Urethroplasty

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: No self-identified genders are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with diagnosis of bulbar urethral stricture upto 2cm in length.
• Patients aged between 18-50 years.
• Patients with non-traumatic bulbar urethral stricture.
• Isolated short (≤ 2 cm) bulbar urethral stricture
• Patient is able and willing to comply with the postoperative protocol.

You may not qualify if:

• Urethral stricture which is completely obliterated stricture.
• Patients with history of hypospadias or previous open urethral surgery.
• Patients with uncontrolled diabetes or Immunocompromised patients.
• Patients unwilling for the follow-up.
• History of pelvic radiation therapy
• Patient with history of urethral instrumentation in last 3 months.
• Lichen sclerosus related strictures.
• Patients with history of erectile dysfunction, priapism or treatment to enhance erectile function.

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead

MeSH Terms

Conditions

Urethral Stricture; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Dr. Riaz ul Haq Professor, FCPS

CONTACT

0092-40-4502470; slmcswl@gmail.com

Dr. Adeel Riaz Consultant, MD

CONTACT

0092-40-4502470; slmcswl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR WAQAS ALI PGR UROLOGY

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share