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CTRI Number  CTRI/2025/10/096166 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Silodosin in preventing post-operative urinary retention after spine surgeries 
Scientific Title of Study   Efficacy Of Oral Silodosin During Peri-Operative Period In Preventing Post-Operative Urinary Retention (POUR) In Spine Surgeries - A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidyadhara Srinivasa 
Designation  Chairman and HOD, Spine Surgery 
Affiliation  Manipal Hospital, Old Airport Road, Bangalore 
Address  Room no. 1, Manipal Comprehensive Spine Care Centre, No. 98, Rustumbagh, Manipal Hospital, Old Airport Road

Bangalore
KARNATAKA
560017
India 
Phone  8948015165  
Fax    
Email  vidya007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vidyadhara Srinivasa 
Designation  Chairman and HOD, Spine Surgery 
Affiliation  Manipal Hospital, Old Airport Road, Bangalore 
Address  Room no. 1, Manipal Comprehensive Spine Care Centre, No. 98, Rustumbagh, Manipal Hospital, Old Airport Road


KARNATAKA
560017
India 
Phone  8948015165  
Fax    
Email  vidya007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vidyadhara Srinivasa 
Designation  Chairman and HOD, Spine Surgery 
Affiliation  Manipal Hospital, Old Airport Road, Bangalore 
Address  Room no. 1, Manipal Comprehensive Spine Care Centre, No. 98, Rustumbagh, Manipal Hospital, Old Airport Road


KARNATAKA
560017
India 
Phone  8948015165  
Fax    
Email  vidya007@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Srinivasa Vidyadhara 
Address  Room no. 1, Manipal Comprehensive Spine Care Centre, No. 98, Manipal Hospital, Old Airport Road, Bangalore - 560017 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidyadhara Srinivasa  Manipal Hospital  Room no. 1, Manipal Comprehensive Spine Care Centre, No. 98, Rustam Bagh, Manipal Hospital, Old Airport Road, Bangalore - 560017, Karnataka
Bangalore
KARNATAKA 		 9845210001

vidya007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: R339||Retention of urine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patients of elective spine surgeries were included in this study.Foleys catheter was removed on the first post operative day and we evaluated for the incidence of post operative urinary retention. All post operative medications with regards to spine surgery remains same in both groups.In comparator group no additional medications were given for it (no silodosin used in this group). 
Intervention  Oral Silodosin  Single dose of oral silodosin (8mg) is given 8 hours after surgery followed by another dose given 4 hours before the voiding trial (removal of foleys catheter), which was done on postoperative day 1. The control group patients were not given any medications for the urinary retention. However, rest all the medications and preoperative protocols were same for both the groups. POUR in was defined as inability to void urine after catheter removal with post void residue of more than 200 ml and needing recatheterisation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients above 18 years of age planned for spine surgery under general anaesthesia were included in the study. 
 
ExclusionCriteria 
Details  Patients with neurological deficits, intra-operative dural tear, neurogenic bladder, cauda equina syndrome or conus medullaris syndrome who need indwelling catheter for a longer duration;
Patients who are non-ambulatory and need indwelling catheter for longer duration of time.
History of urinary retention requiring continuous or intermittent catheterization;
Confirmed or suspected urethral stricture, history of prostatic or bladder neck surgery or cases of prostate cancer;
History of unstable angina or myocardial infarction or cerebrovascular accidents with residual disease;
History of syncope or orthostatic hypotension;
An active prescription for an alpha receptor antagonist medication;
Impaired renal function serum creatinine more than 1.4 mg/dL or eGFR less than 90 mg/mmol;
Chronic Liver disease;
Patients taking drugs that is known to have interaction with Silodosin - Clarithromycin, Anti-retroviral drugs, Ketoconazole/Itraconazole;
Known allergy to Silodosin;
Patients unwilling or unable to give consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is the Incidence of Post operative urinary retention (POUR) in the post operative period after removal of Foleys catheter.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Length of stay, Complications, Readmission  30 days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "151"
Final Enrollment numbers achieved (India)="151" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) 31/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Post operative urinary retention (POUR) is a frequently encountered post operative event with an incidence ranging from 10%-20% in Orthopaedic surgeries. The rates of POUR has been reported even higher in spine surgeries due to the use of general anesthesia, longer duration of surgery, surgeries involving the lower lumbar levels and old age. With this background we hypothesised that the use of oral silodosin (superselective alpha 1 blocker) can decrease the rate of POUR in patients undergoing spine surgeries.

Hypothesis - The use of super-selective alpha agonist like silodosin in the peri-operative period will reduce the incidence of post operative urinary retention in spine surgeries.

Patients will be randomly allocated into two groups -

Interventional group (Group 1) - Tab Silodosin 8mg will be given 8 hours after surgery followed by another dose given 4 hours before the trial voiding. Urinary catheter will be removed on the 1st post operative day.

Control group (Group 2) - No additional medication shall be given for urinary retention. However, rest all the medications and protocols will remain the same.

Primary Outcomes assessed - Incidence of Post operative urinary retention

Benefits - To provide quality high evidence and improve post operative care in line with concept of ERAS (Early recovery after surgery) and help in preparing a guideline for patients undergoing day care surgery or being discharged early with reduced risk of POUR.

 
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