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

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

Urethroplasty is considered as a gold standard in treatment of urethral stricture disease having success rate of more than 93% in terms of recurrence of stricture. The objective of the study is to compare the outcome between 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 stricture upto 2cm in length. It will be a Randomized Controlled Trial (RCT) in which 94 patients admitted in Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. The 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 carried out. Detailed history of urinary symptoms, Sexual function, catheterization, instrumentation, urinary tract infection and trauma will be taken to obtain the cause of stricture. Demographic information like name, age, and contact number will be recorded. Investigations will include preoperative complete blood count, renal function test, liver function test, urine complete examination, ultrasonogram kidney, ureter and bladder with post void residual volume (PVR) uroflowmetry and retrograde urethrogram for diagnosis and length of stricture. Other parameters of study will be length of hospital stay, postoperative complication such as graft failure, wound infection, urinary tract infection and fistula formation. Data will be collected through proforma, which will be entered and analyzed using statistical package for social sciences version 26.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between qualitative variables. An Independent sample t-test will be applied for quantitative variables. P-value <0.05 will be considered significant. It is anticipated that the Tunica Vaginalis Graft (TVG) Urethroplasty provides better outcome as compared to excision and primary anastomosis (EPA) urethroplasty.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction; Urethral Stricture
• Intervention / Treatment: Procedure: Excision and Primary Anastomosis Urethroplasty; Procedure: Tunica Vaginalis Graft Urethroplasty

Detailed Description

A proforma will be prepared by researcher and finalized after pre-testing. The patients admitted in Sahiwal Teaching Hospital, Sahiwal will be assessed by the researcher himself and results will be noted on the proforma. Patients will be admitted to hospital one day before surgery. Detailed history of urinary symptoms, sexual function, catheterization, instrumentation, urinary tract infection, trauma will be taken to obtain the cause of stricture. Demographic information like name, age, and contact number will be recorded. Investigations will include preoperative complete blood count, renal function test, liver function test, urine complete examination, ultrasonogram kidney, ureter and bladder with post void residual volume (PVR), uroflowmetry and retrograde urethrogram for diagnosis and length of stricture. A midline perineal incision will be made in lithotomy position from the perineoscrotal junction to about 1 cm from the anal margin. 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. 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 30 French bougie and the distal urethra will then be spatulated ventrally. The anastomosis will be done using interrupted sutures of 4-0 polydioxanone (PDS). While in Group B (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. Graft outlined on the parietal tunica vaginalis and carefully dissected avoiding injury to the testis or epididymis. Hemostasis is secured. The harvested tunica vaginalis graft is placed on a sterile surface with the serosal surface facing upward. It is then trimmed to the required size. The graft is kept moist in normal saline until applied to the urethral site. 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 (Mridha et al., 2023). 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 (Siegel et al., 2024). Ventral urethrotomy is closed over the catheter using absorbable sutures. A 16 French soft silicone catheter will be kept in place for 2-3 weeks for drainage of urine. The bulbospongiosus muscle will be closed in the midline using interrupted 3-0 vicryl sutures. A suction drain is placed in the perineum overlying the muscle, and Colles' fascia is closed using running 3-0 vicryl, followed by skin closure with running 4-0 chromic. A clear adhesive dressing is placed, and the patient is placed supine. 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-ups will be conducted at scheduled intervals as per the prescribed proforma. Data will be collected through proforma.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Riaz ul Haq Professor, FCPS; Phone Number: 0092-40-4502470; Email: slmcswl@gmail.com
• Study Contact Backup: Name: Dr. Adeel Riaz Consultant, MD; Phone Number: 0092-40-4502470; Email: slmcswl@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Excision and Primary Anastomosis Urethroplasty	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 will be done using interrupted sutures of 4-0 polydioxanone (PDS).
Other: Tunica Vaginalis Graft Urethroplasty	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Urine Flow Rate (Qmax)	The highest rate of urine flow in milliliters per second (mL/s) as measured by uroflowmetry. The primary analysis will compare the mean change in Qmax postoperatively.	12 months
Erectile Dysfunction	Erectile dysfunction (ED) has been defined as the inability to attain or maintain penile erection sufficient for successful sexual intercourse. The severity of erectile dysfunction is often described as mild, moderate, or severe according to International Index of Erectile Function (IIEF5) questionnaire, with a score of 1-7 indicating severe ED, 08-11 moderate ED, 12-16 mild-moderate ED, 17-21 mild ED, and 22-25 no ED.	12 months

Collaborators and Investigators

• Sponsor: Sahiwal medical college sahiwal

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Urethral Diseases; Urethral Obstruction; Erectile Dysfunction; Urethral Stricture
• Other Study ID Numbers: 369/IRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No