| CTRI Number |
CTRI/2024/08/073039 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the outcomes of two surgical methods for urethral narrowing - reconstruction by anterior approach versus reconstruction by posterior approach |
|
Scientific Title of Study
|
Prospective Randomised study Comparing Functional outcomes of Bulbospongiosus Muscle-Sparing Augmentation Urethroplasty with Dorsal and Ventral Approaches for Bulbar Urethral Strictures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavatej Enganti |
| Designation |
Consultant Urologist |
| Affiliation |
Asian Institute of Nephrology and Urology |
| Address |
Room no 2, Department of Urology, Asian Institute of Nephrology and Urology, 6-3-562/A, Erramanzil colony, Somajiguda, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9652342642 |
| Fax |
|
| Email |
bhavatej@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavatej Enganti |
| Designation |
Consultant Urologist |
| Affiliation |
Asian Institute of Nephrology and Urology |
| Address |
Room no 2, Department of Urology, Asian Institute of Nephrology and Urology, 6-3-562/A, Erramanzil colony, Somajiguda, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9652342642 |
| Fax |
|
| Email |
bhavatej@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh M |
| Designation |
DNB Urology Resident |
| Affiliation |
Asian Institute of Nephrology and Urology |
| Address |
Room no 220 (2nd floor), Department of Urology, Asian Institute of Nephrology and Urology, 6-3-562/A, Erramanzil colony, Somajiguda, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8939448235 |
| Fax |
|
| Email |
drdinesh6893@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asian Institute of Nephrology and Urology, 6-3-562/A, Erramanzil colony, Somajiguda, Hyderabad, Telangana, India.
Pin code: 500082 |
|
|
Primary Sponsor
|
| Name |
Bhavatej Enganti |
| Address |
Asian Institute of Nephrology and Urology, 6-3-562/A, Erramanzil colony, Somajiguda, Hyderabad |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhavatej Enganti |
Asian Institute of Nephrology and Urology |
Department of Urology, Asian Institute of Nephrology and Urology, 6-3-562/A, Erramanzil colony, Somajiguda, Hyderabad
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9652342642
bhavatej@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AINU Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dorsal onlay BMG augmentation urethroplasty |
A midline perineal incision is made, and the layers are dissected to expose the bulbospongiosus muscle. A soft catheter is then inserted through the meatus to locate the distal aspect of the stricture. The bulbospongiosus muscle is carefully preserved, and mobilization of the bulbar urethra is carried out on the left side to access the dorsal aspect of the bulbar urethra. A midline dorsal urethrotomy is performed, and the segment of the stricture in the bulbar urethra is visualized and examined. The urethral incision is extended distally and proximally until a urethral lumen of 30 Fr caliber (using a metal bougie) is reached and confirmed. The length of the stricture is measured using markings on the ureteric catheter, while the urethral plate width is measured with calipers. Traction sutures are carefully placed on the bulbar urethra to expose the corporal bodies, followed by the placement of three apical interrupted sutures to align the buccal mucosal graft (BMG) with the proximal normal urethral mucosa. The BMG is positioned on the dorsal aspect and quilted onto the underlying corpora. The medial margin of the urethra and the BMG are approximated using 4-0 polyglactin sutures. Distal apical sutures are then taken to align the BMG with the distal urethral mucosa, and a urethral catheter is inserted. The lateral margins of the urethra and the BMG are approximated, ensuring adequate hemostasis before closing the perineal surgical site in layers and applying a compressive dressing. |
| Intervention |
Ventral onlay BMG augmentation urethroplasty |
A midline perineal incision is performed, and the distal extent of the bulbospongiosus muscle is identified as a landmark. The location of the distal extent of the bulbar urethral stricture is determined by passing a soft catheter through the urethra. Subsequently, the bulbospongiosus muscle is identified, and a midline incision is made specifically in the proximal two-thirds of the muscle, directly overlying the bulbar urethral stricture, while preserving the distal one-third of the muscle.
The width of the corpus spongiosum is measured, followed by a ventral sagittal urethrotomy that is performed to open the stricture urethra, guided by a pre-placed ureteric catheter. The stricture and urethral plate are then evaluated, extending the assessment 1 cm proximally and distally from the normal urethral lumen. Ventral augmentation of the urethral lumen is accomplished using a buccal mucosal graft (BMG). Both urethral margins are sutured with BMG using polyglactin (4-0) sutures over a 14 Fr silicone catheter. The ventral onlay BMG is quilted with the corpus spongiosum using interrupted polyglactin (4-0) sutures, and the adventitia of the corpus spongiosum is approximated after ensuring adequate hemostasis.
Finally, the proximal two-thirds of the bulbospongiosus muscle is closed over the ventral urethrotomy suture line, and the perineal surgical site is closed in layers.
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patients undergoing Primary Augmentation urethroplasty for Anterior urethral strictures involving only the proximal bulbar urethra measuring ≥ 2 cm and less ≤ 5cm |
|
| ExclusionCriteria |
| Details |
1.Traumatic bulbar urethral strictures.
2.Post-prostatectomy bulbar urethral strictures
3.Bulbar urethral strictures following periurethral abscess
4.Patients with a history of genitourinary tuberculosis, malignancy, or radiation affecting the bladder, prostate and urethra.
5.Redo-urethroplasty
6.Non availability of buccal mucosa or poor oral hygiene
7.Patients with psychiatric and neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative urine flow following dorsal onlay bulbospongiosus muscle-preserving augmentation urethroplasty with ventral onlay bulbospongiosus muscle-preserving augmentation urethroplasty for bulbar urethral strictures |
Once in 6 months in first year and annually thereafter for 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the erectile function, ejaculatory function and post void dribbling following dorsal onlay bulbospongiosus muscle-preserving augmentation urethroplasty with ventral onlay bulbospongiosus muscle-preserving augmentation urethroplasty for bulbar urethral strictures |
Once in 6 months in first year and annually thereafter for 2 years |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients of age >21years and <60 years undergoing Primary Augmentation urethroplasty for Anterior urethral strictures involving only the proximal bulbar urethra measuring ≥ 2 cm and ≤ 5cm will be included in the study. Study participants will be randomised into 2 groups - Ventral onlay or Dorsal onlay. All patients will undergo the procedure under general anaesthesia in lithotomy position. Bulbospongiosus muscle will be preserved and buccal mucosal graft will be harvested in both groups. A ventral urethrotomy incision will be made and ventral augmentation of graft will be done for those in Ventral onlay group. A dorsal urethrotomy incision after one sided urethral mobilisation followed by dorsal augmentation of graft will be done for those in Dorsal onlay group. All patients will undergo catheter removal after 3 weeks and will be followed up once in 6 months in initial year and annually thereafter. During each visit, patients will be evaluated for outcomes in terms of PROM-USS questionnaire for surgery related outcome, IIEF-5 and MSHQ-EjD questionnaire for erectile and ejaculatory functions respectively. Data regarding the functional outcome measures will be analysed and compared between the two groups. |