Comparative efficacy of tamsulosin vs. solifenacin vs. mirabegron in relieving double J stent-related lower urinary tract symptoms (LUTS): A randomised control trial
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AIIMS JODHPUR
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Using the Ureteric stent symptom score (USSQ), we will be investigating the efficacy of tamsulosin, solifenacin, and mirabegron in lowering DJ stent related symptoms in this study.
Overview
Brief Summary
Double-J (DJ) stents, commonly used to relieve ureteral obstructions, often cause lower urinary tract symptoms (LUTS) such as pain, haematuria, and urinary tract infections, significantly impacting patients’ quality of life. These symptoms primarily result from bladder irritation and ureteral spasms caused by the stent’s positioning and movement. While alpha-blockers like tamsulosin and anticholinergics like solifenacin have shown effectiveness in managing these symptoms, the role of beta-3 agonists, such as mirabegron, is less explored despite it’s success in treating overactive bladder (OAB). With limited research comparing the efficacy of these medications for DJ stent-related LUTS, there is a critical need for further studies to address this gap and identify optimal treatment strategies to enhance patient care.
Hypothesis: Compared to other medications, mirabegron shows comparable results on LUTS and performs better on overactive bladder symptoms due to DJ stents. Tamsulosin shows similar results to that of Mirabegron, and there is no additional benefit of using the combination.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Presence of a Double J stent in the urinary tract.
- •• Complaints of lower urinary tract complaints.
Exclusion Criteria
- •Previous treatment with any of the study medications.
- •Presence of other significant urinary tract pathology.
- •Pregnancy or breastfeeding.
- •Any condition that may interfere with the study assessments or participation.
Outcomes
Primary Outcomes
Using the Ureteric stent symptom score (USSQ), we will be investigating the efficacy of tamsulosin, solifenacin, and mirabegron in lowering DJ stent related symptoms in this study.
Time Frame: Baseline, 2 weeks and 4 weeks.
Secondary Outcomes
- To study the impact of LUTS on quality of life (QOL) in patients with DJ stent. To identify the factors that increase the incidence of LUTS in patients with DJ stent.
Investigators
Ankit Shettar
AIIMS Jodhpur