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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

EVALUATION OF TAMSULOSIN VERSUS MIRABEGRON IN URETERIC STENT RELATED SYMPTOMS- A RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022115
Enrollment
90
Registered
2019-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: mirabegron: 50mg orally, once daily for 15 days Control Intervention1: tamsulosin: 0.4mg orally, once daily before sleep for 14 days

Sponsors

Dr Josef B Pachikara
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of Tamsulosin and Mirabegron in ureteral stent related symptoms.Timepoint: 2 weeks

Secondary

MeasureTime frame
to assess quality of life in patients taking tamsulosin and mirabegron for ureteral stent related symptoms as measured by USSQ quality of life scaleTimepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Josef B Pachikara

govt medical college trivandrum

drgsatheeshkurup@gmail.com9446455385

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026