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CTRI Number  CTRI/2019/11/022115 [Registered on: 22/11/2019] Trial Registered Prospectively
Last Modified On: 20/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out which is the better drug between tamsulosin and mirabegron in treating patients having ureteric stents for stent related urinary complaints 
Scientific Title of Study   EVALUATION OF TAMSULOSIN VERSUS MIRABEGRON IN URETERIC STENT RELATED SYMPTOMS- A RANDOMISED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satheesh kumar 
Designation  Additional professor 
Affiliation  govt medical college trivandrum 
Address  dept of Urology govt medical college trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9446455385  
Fax    
Email  drgsatheeshkurup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satheesh kumar 
Designation  Additional professor 
Affiliation  govt medical college trivandrum 
Address  dept of Urology govt medical college trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9446455385  
Fax    
Email  drgsatheeshkurup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Josef B Pachikara 
Designation  senior resident 
Affiliation  govt medical college trivandrum 
Address  dept of Urology govt medical college trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9717759590  
Fax    
Email  josefbpachikara@gmail.com  
 
Source of Monetary or Material Support  
Dr Josef B Pachukara flat !!a tower A sreedhanya planet x sreekaryom, trivandrum pin-695017 
 
Primary Sponsor  
Name  Dr Josef B Pachikara 
Address  Dept of Urology Govt medical college trivandrum 
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 Josef B Pachikara  Government medical college trivandrum  urology opd, ground floor super speciality block govt medical college trivandrum
Thiruvananthapuram
KERALA 
8717759590

josefbpachikara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
human ethics commitee, govt medical college trivandrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N201||Calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mirabegron  50mg orally, once daily for 15 days 
Comparator Agent  tamsulosin  0.4mg orally, once daily before sleep for 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who have underwent semirgid ureteroscopy with DJ stenting.
2. Only patients with uncomplicated ureteric calculi.
3 Patients aged 18 years to 60 years. 
 
ExclusionCriteria 
Details  1. Patients with growth in Urine culture or having symptomatic urinary tract infection.
2. Patients who may need bilateral stent insertion for acute obstruction / obstructive uropathy
3. Male patients with history of prostatic enlargement, prostatitis or prostatic cancer related lower urinary tract symptoms
4. Females with lower urinary tract symptoms related to any form of urinary incontinence, uterine/cervical/vaginal prolapse, or obstruction related to malignancy.
5. History of chronic or recent α-blocker or analgesic drug use were excluded.
6. Pregnancy,
7. Bleeding disorders,
8. Patients with concomitant other lower tract pathology like bladder cancer, bladder outlet obstruction with or without stones, urethral stricture.
9. Patients with simultaneous renal calculus.
10. Patients who underwent open surgery for ureteric calculi previously.
11. Patients not fulfilling inclusion criteria.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Tamsulosin and Mirabegron in ureteral stent related symptoms.  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to assess quality of life in patients taking tamsulosin and mirabegron for ureteral stent related symptoms as measured by USSQ quality of life scale  2 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   01/12/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ureteric stents are used often by Urologists following ureteroscopy for prevention of ureteric obstruction from oedema and or stone fragments. They are often associated with pain, need to void often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS in short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms.

Mirabegron is a beta agonist used to decrease OAB symptoms and has been found to be effective in treating patients with stent related symptoms. Mirabegron functions to mediate relaxation of the detrusor muscle. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore is useful in treating stent symptoms, without the bothersome side effects commonly seen with antimuscarinic medications. The aim of this study is to compare Tamsulosin and Mirabegron in treating stent related symptoms.

 
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