| CTRI Number |
CTRI/2025/08/092492 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A comparative study on the effect of Tamsulosin versus Silodosin in post operative urinary retention patients ” |
|
Scientific Title of Study
|
A comparative study on the effect of Tamsulosin versus Silodosin in post operative urine retention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vigneshwaran B |
| Designation |
Post graduate MS General surgery |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Sri Manakula Vinayagar Medical College and Hospital, Department of general surgery,kalitheerthalkuppam,Madagadipet,Puducherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9486626085 |
| Fax |
|
| Email |
vigneshwaran5789@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vigneshwaran B |
| Designation |
Post graduate MS General surgery |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Sri Manakula Vinayagar Medical College and Hospital, Department of general surgery,kalitheerthalkuppam,Madagadipet,Puducherry Sri Manakula Vinayagar Medical College and Hospital, Department of general surgery,kalitheerthalkuppam,Madagadipet,Puducherry Pondicherry PONDICHERRY 605107 India |
| Phone |
9486626085 |
| Fax |
|
| Email |
vigneshwaran5789@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vigneshwaran B |
| Designation |
Post graduate MS General surgery |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Sri Manakula Vinayagar Medical College and Hospital, Department of general surgery,kalitheerthalkuppam,Madagadipet,Puducherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9486626085 |
| Fax |
|
| Email |
vigneshwaran5789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Dr Vigneshwaran B |
| Address |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| 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 |
| DrSBabu |
Sri Manakula Vinayagar medical college and hospital |
Department of general surgery,kalitheerthalkuppam,madagadipet,pondicherry Pondicherry PONDICHERRY |
9442119573
drsbabu459@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z69-Z76||Persons encountering health services in other circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Silodosin |
Patients undergoing abdominal, pelvic, perineal surgeries are given drug prophylaxis either tablet Tamsulosin 0.4mg or tablet Silodosin 8mg 12 hours before the procedure. Group A will be Silodosin and Group B will be Tamsulosin. All patients were closely followed for 24 hours postoperatively and any voiding difficulties or any urinary retention were recorded. In case of urinary retention, urethral catheterization is done |
| Intervention |
Tamsulosin |
Patients undergoing abdominal, pelvic, perineal surgeries are given drug prophylaxis either tablet Tamsulosin 0.4mg or tablet Silodosin 8mg 12 hours before the procedure. Group A will be Silodosin and Group B will be Tamsulosin. All patients were closely followed for 24 hours postoperatively and any voiding difficulties or any urinary retention were recorded. In case of urinary retention, urethral catheterization is done |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 40 years of both sexes
2. Patients undergoing abdomen, pelvic, perineal surgeries
3. Patients anaesthetized by general and spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with symptomatic benign prostate hypertrophy
2. Renal impairment, hepatic impairment
3. Previous neurological disease
4. Urethral stricture, urinary incontinency
5. Patients with indwelling catheter
6. Patients with serum creatinine greater than 1.6mg/dl
7. Prostate cancer, bladder cancer
8. Cardiac related ill patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of prophylactic Tamsulosin versus Silodosin in post operative retention of urine |
Till postoperative period of 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of catheterisation following surgeries with prophylactic Tamsulosin versus Silodosin under general and spinal anesthesia |
Till postoperative period of 24 hours |
|
|
Target Sample Size
|
Total Sample Size="334" Sample Size from India="334"
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 2 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Those fulfilling the above inclusion and are not in the exclusion criteria will be participants of the study. The participants will be alternatively divided into two groups. The following investigations were carried out in all patients participating in this study i.e. complete blood count, blood urea and serum creatinine, total serum bilirubin, ALP, SGOT, SGPT, ECG, Chest X Ray-PA view, Urine routine, Ultrasound abdomen and pelvis. Patients of General Surgery undergoing abdominal, pelvic, perineal surgeries are given drug prophylaxis either Silodosin in the form 8 mg tablet or Tamsulosin 0.4 mg 12 hours before the procedure to patients. Group A will be given Silodosin . Group B is Tamsulosin. All patients were closely followed for 24 hours post operatively and any voiding difficulties or urinary retention were recorded. Acute urinary retention was diagnosed when a patient was unable to pass urine, feels pain, has a palpable mass in suprapubic region and encouraging the patient to stand up and walk were unsuccessful and urethral catheterization seemed inevitable. The functional outcome will be evaluated based on VAS score in case of Postoperative urine retention, need for urethral catheterization. |