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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003706

Enrollment

103

Registered

2019-04-03

Start date

2018-12-10

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

None listed

Interventions

Drug : A group: Control group B group: ß3 agonist (mirabegron tablet 50mg, QD, Oral) C group: anticholinergics (solifenacin tablet 5mg, QD, Oral) The patients of the study group received the study med

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
USSQ (Body pain subscore)	—

Secondary

Measure	Time frame
USSQ (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	—

Countries

Korea, Republic of

Contacts

Public ContactWonho Jung

Keimyung University Dongsan Medical Center

jeongwon-ho@hanmail.net+82-53-250-7643

Outcome results