Health Condition 1: Q62- Congenital obstructive defects ofrenal pelvis and congenital malformations of ureter Health Condition 2: N20-N23- Urolithiasis
Conditions
Interventions
Intervention1: Mirabegron: Patients with stents in situ and allocated into mirabegron arm shall be administered 50 mg oral mirabegron once a day orally
Duration 4 weeks for all endourological procedu
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: All patients above 18 years of age undergoing ureteral stent placement following any of the following surgeries/ procedures shall be enrolled in the study 1. Ureteroscopic lithotripsy (URSL) 2. Retrograde Intra-renal surgery (RIRS) 3. Percutaneous nephrolithotomy (PCNL) 4. Robot-assisted/ laparoscopic pyeloplasty 5. Extracorporeal shock wave lithotripsy (ESWL)
Exclusion criteria
Exclusion criteria: 1. Concomitant use of alpha blockers, anticholinergics, calcium channel blockers, corticosteroids and analgesics 2. Patients with long term indwelling ureteral stent prior to surgery ( > 4 weeks) 3. Patients undergoing open ureteral surgery 4. Patients with Overactive Bladder, Benign prostatic hyperplasia (IPSS score ï?³8), and Neurogenic bladder 5. Patients with pre-operative untreated Urinary tract infection (UTI) 6. Pregnant or breast feeding women 7. Placement of bilateral ureteral stents 8. Patients with moderate or severe cardiovascular/cerebrovascular disease, severe uncontrolled hypertension or hepatic dysfunction 9. Patients with incomplete clearance of calculi following surgery 10. Patients with prior history of pelvic surgery or irradiation 11. Patients with prior history of bladder or prostatic surgery 12. Patients with other acute medical conditions that might influence the USSQ pain index 13. Any intra-operative event or surgeonâ??s discretion necessitating retention of ureteral stent in situ for more than 6 weeks 14. Incomplete clearance of calculus after 2 cycles of ESWL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy and safety of mirabegron in relieving urinary symptoms in patients with ureteral stents measured by urinary index score of ureteric stent symptom questionnaire (USSQ) as compared to tamsulosin and solifenacin in a non-inferiority trial.Timepoint: Completion of follow up of target sample size | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of mirabegron in relieving ureteral stent related symptoms in other domains of USSQ viz. Pain Index score, General health Index score, Work performance score, Sexual matters score, Global quality of Life with stent in situ and additional problemsTimepoint: Completion of follow up of target sample size;To compare the adverse reaction profile of the tamsulosin, mirabegron and solifenacin in patients with ureteral stentsTimepoint: Completion of follow up of target sample size;To compare the efficacy of tamsulosin and solfenacin in relieving ureteral stent related symptoms measured by various domains of USSQ.Timepoint: Completion of follow up of target sample size | — |
Countries
India
Contacts
Public ContactSantosh Kumar
PGIMER
Outcome results
None listed