| 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
|
|
|
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
|
|
|
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. |