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CTRI Number  CTRI/2022/05/042897 [Registered on: 30/05/2022] Trial Registered Prospectively
Last Modified On: 28/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Tamculosin for urinary retention in hip fracture patients 
Scientific Title of Study   Efficacy and safety of tamsulosin in prevention of post-operative urinary retention in hip fracture: a randomized double-blind placebo-controlled study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujit Kumar Tripathy 
Designation  Additional Professor, Orthopaedics 
Affiliation  AIIMS Bhubaneswar 
Address  A Block, Room No 17, Depart of Orthopedics AIIMS Bhubaneswar Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9438884155  
Fax    
Email  sujitortho@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Sujit Kumar Tripathy 
Designation  Additional Professor, Orthopaedics 
Affiliation  AIIMS Bhubaneswar 
Address  A Block, Room No 17 Department of Orthopedics AIIMS Bhubaneswar-751019 Sijua, Patrapada AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884155  
Fax    
Email  sujitortho@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Sujit Kumar Tripathy 
Designation  Additional Professor, Orthopaedics 
Affiliation  AIIMS Bhubaneswar 
Address  A Block, Room No 17 Department of Orthopaedics AIIMS Bhubaneswar-751019 Sijua, Patrapada AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884155  
Fax    
Email  sujitortho@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua, Patrapada AIIMS Bhubaneswar 
Type of Sponsor  Government medical college 
 
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 Sujit Kumar Tripathy  AIIMS Bhubaneswar  A Block, Room No 17 Department of Orthopaedics AIIMS Bhubaneswar-751019 Sijua, Patrapada
Khordha
ORISSA 		 9438884155

sujitortho@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Starch capsule OD from the time of admission to two days postoperatively 
Intervention  Tamsulosin  Tamsulosin 0.4mg OD from the time of admission to two days postoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  1. All patients undergoing hip fracture surgery (ORIF or arthroplasty)
2. ≥18 years of age.
3. Patients willing to participate
 
 
ExclusionCriteria 
Details  1. History of neurogenic bladder or urological problems requiring routine intermittent catheterization
2. Patients unable to take an oral medication
3. Patient who would require an indwelling catheter for other reasons, or patients who needed catheterisation during admission to the emergency for voiding difficulty
4. Patients with systolic blood pressure <100 mmhg or orthostatic hypotension
5. Pregnant women
6. Associate trauma of spine or pelvis
7. Patients taking medications for lower urinary tract symptoms or who had previously undergone prostatectomy
8. Patients with severe liver or kidney disease
9. Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir/ritonavir, lopinavir/ritonavir, or conivaptan), use of a 5-alpha reductase inhibitor medication, the use of sildenafil, tadalafil, or vardenafil, history of an allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin,
Terazosin, or phenoxybenzamine),
10. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection
11. Congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
12. Psychiatric illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Number of patients developing postoperative urinary retention (POUR)  6 hours of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. No. of patients needing urinary catheter placement (unable to void, bladder scan with 500 mL residual urine or patient discomfort)
2. No. of intermittent catheterization
3. Total days of hospital stay
4. Analgesic use
5. No. of patient developing UTI or surgical site infection
6. No. of patient developing other complications such as VTE, pneumonia, hypotension or cardiac event
 		 within hospital admission period 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study will be a randomized, double-blind, placebo-controlled trial comparing perioperative tamsulosin therapy to placebo for the prevention of POUR in adult patients undergoing hip fracture surgery

Participants:

The adult patients with hip fractures admitted to the Department of Orthopaedics at AIIMS Bhubaneswar for surgical intervention will be included. The patients meeting the inclusion criteria will be recruited after obtaining their consent.

Treatment allocation and randomization:

The patients will be randomized to the treatment arm or placebo arm based on computer-generated randomizations codes. Group allocation will be concealed in a sealed opaque envelope by a third party (independent researcher) prior to the treatment. The participants and clinical investigators will remain blinded to the drugs.

Interventions and management:

The participants in the treatment group will receive tamsulosin 0.4 mg OD from the time of admission to two days postoperatively. The placebo group will receive a starch capsule in a similar manner.

Perioperative course

All hip fracture patients undergoing hip fracture fixation or arthroplasty will be assigned to one of the groups. The patient will be operated on under regional anesthesia or general anesthesia. They will be catheterized during surgical induction or just before the surgery. The postoperative pain medication will be uniform. All patients will receive Paracetamol 1gm qid. The Diclofenac and tramadol injection will be given on demand. The catheter will be removed the next day morning (within 24 hrs). The patient should be able to void normally within 6 hrs of catheter removal with a bladder scan volume of <200ml. If the patient will not be able to void within 6 hrs, he will be evaluated with a bladder scan. Inability to void within 6hrs, symptoms of abdominal discomfort or urinary retention, post-void residual bladder volume of >200 ml, and urinary retention of >200ml after 6 hrs of catheter removal will be considered as the development of POUR. The patient will be intermittently catheterized for 24 hours in case of abdominal discomfort and bladder volume >500ml. If it persists beyond 24 hours, the indwelling catheter will be placed and a urology consultation will be sought.  
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