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Effect of ß3 agonist for treatment of ureteral stent-related symptoms

Not Applicable
Recruiting
Conditions
Diseases of The genitoruinary system
Registration Number
KCT0003706
Lead Sponsor
Keimyung University Dongsan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
103
Inclusion Criteria

Adult patients(aged over 18 years men and women) who have ability to understand the ICF(informed consent form), willing and adhere to the consent specified in this protocol.
- Patients who underwent unilateral retrograde rigid ureteroscopic or flexible ureteroscopic
lithotripsy with planned ureteral stent insertion for kidney and ureter stone.

Exclusion Criteria

- Not signed informed consent form (ICF)
- Urogenital cancer that currently requires treatment
- Underwent bilateral ureteroscopic surgery;
- Serious comorbidity (infection, immunocompromised state, renal failure, cardiovascular disease, liver complaint, nerve disorder and mental illness)
- Severe coronary and cerebrovascular disease
- Acquired or congenital QT prolongation state
- Patient who taking CYP3A inhibitor
- Severe liver disease (2 times higher than normal level)
- Severe renal disease (GFR 15~29mL/min/1.73m2)
- Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] =180mmHg or diastolic BP =110 mmHg).
- Patient who taking ß3 agonist, anticholinergics, steroid, Calcium Channel Blockers, analgesic or a-blockers.
- During pregnancy or lactation.
- Ureteropathy like ureteral stricture.
- Patient who contraindicated taking ß3 agonist and anticholinergics
- History of pelvic surgery or irradiation
- History of bladder or prostate surgery
- History of percutaneous, laparoscopic, robotic or open urinary stone surgery
- Neurogenic bladder or overactive bladder
- Patient who inadequate participation in the study at the discretion of the investigator

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
SSQ (Body pain subscore)
Secondary Outcome Measures
NameTimeMethod
SSQ (Urinary symptoms subscore);USSQ (General health subscore);USSQ (Work performance subscore);USSQ (Sexual matters subscore);USSQ (Additional problems subscore);IPSS questionnaire;Uroflowmetry/Residual urine (UFM/PVR);Medication compliance and side effects
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