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

Official title

Comparison of Outcome Between Excision and Primary Anastomosis Urethroplasty and Tunica Vaginalis Graft Urethroplasty in Patients With Bulbar Urethral Stricture Upto 2cm in Length : A Randomized Controlled Trial

Overview

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.

Detailed description

A proforma will be prepared by the researcher and finalized after pre-testing. The patients admitted to Sahiwal Teaching Hospital, Sahiwal will be assessed by the researcher, and the results will be recorded on the proforma. Patients will be admitted to the hospital one day before surgery.

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.

A midline perineal incision will be made in the lithotomy position from the perineoscrotal junction to about 1 cm from the anal margin. The incision will be deepened through the subcutaneous tissue and Colles' fascia to expose the bulbospongiosus muscle. The bulbospongiosus muscle will be divided in the midline and retracted.

In Group A (excision and primary anastomosis urethroplasty) patients, an incision will be made down onto the catheter in the ventral midline. The urethra will be divided with scissors proximally and distally until healthy urethra is reached. 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 30 French bougie. The distal urethra will then be spatulated ventrally. The anastomosis will be performed using interrupted 4-0 polydioxanone (PDS) sutures.

In Group B (tunica vaginalis graft urethroplasty) patients, an incision will be made onto the urethra in the ventral midline along the length of the stricture, extending into the healthy proximal and distal urethra, and stay sutures will be positioned. The tunica vaginalis graft will be harvested by making a small vertical or transverse hemiscrotal incision. The dartos fascia will be divided to expose the tunica vaginalis. The testis will be gently delivered through the incision. The graft will be outlined on the parietal tunica vaginalis and carefully dissected while avoiding injury to the testis or epididymis. Hemostasis will be secured. The harvested tunica vaginalis graft will be placed on a sterile surface with the serosal surface facing upward and trimmed to the required size. The graft will be kept moist in normal saline until applied to the urethral site. The tunica vaginalis defect will be approximated, and the testis will be returned to the scrotum. The dartos fascia and skin will be 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 graft take. The ventral urethrotomy will be closed over the catheter using absorbable sutures.

A 16 French soft silicone catheter will be kept in place for 2-3 weeks for urinary drainage. The bulbospongiosus muscle will be closed in the midline using interrupted 3-0 Vicryl sutures. A suction drain will be placed in the perineum overlying the muscle, and Colles' fascia will be closed using running 3-0 Vicryl sutures, followed by skin closure with running 4-0 chromic sutures. A clear adhesive dressing will be applied, and the patient will be placed in the supine position. The per-urethral Foley catheter will be removed 2-3 weeks after the procedure.

All procedures will be performed by experienced urologists using standardized surgical techniques to ensure consistency. Postoperative follow-up will be conducted at scheduled intervals as specified in the prescribed proforma. Data will be collected using the proforma.

Interventions

• Procedure Excision and Primary Anastomosis Urethroplasty
  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
• Procedure Tunica Vaginalis Graft Urethroplasty
  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 tun

Primary outcome measures

• Stricture Recurrence [Time frame: 12 months]

Secondary outcome measures (2)

• Maximum Urine Flow Rate (Qmax) [Time frame: 12 months]
• Erectile Dysfunction [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07668973 · 369/IRB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗