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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  
Name  Address 
Nil   
 
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  
Status 
Not Applicable 
 
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.

 
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