Comparison of Mirabegron, Tamsulosin and Solifenacin for relieving stent related symptoms.

Phase 2

Completed

• Conditions: Health Condition 1: Q62- Congenital obstructive defects ofrenal pelvis and congenital malformations of ureterHealth Condition 2: N20-N23- Urolithiasis

• Registration Number: CTRI/2019/02/017808
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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