Catheter-Related Bladder Discomfort (CRBD)
Conditions
Interventions
Control Group:Placebo
Treatment Group:Mirabegron 50 mg once daily + Celecoxib 200 mg twice daily, orally.
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–80 years, both genders. 2.Diagnosed with bladder mass by imaging or cystoscopy, scheduled for transurethral resection of bladder tumor (TURBT). 3.Planned to undergo elective TURBT under general or neuraxial anesthesia. 4.Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Drug-Related: (1) Allergy to mirabegron, celecoxib, any other component of the study drugs, sulfonamides, or other NSAIDs. (2) Severe uncontrolled hypertension (systolic BP =180 mmHg or diastolic BP =110 mmHg). (3) Current use of potent CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine). (4) Active peptic ulcer or history of gastrointestinal bleeding. (5) Patients who have undergone coronary artery bypass grafting (CABG) electively or within the past 30 days; severe congestive heart failure (NYHA =II), recent myocardial infarction, unstable angina, recent stroke or transient ischemic attack. (6) Use of anticoagulants or dual antiplatelet therapy. 2.Organ Function-Related: (1) ALT/AST > 3× ULN; (2) eGFR = III. (2) Severe arrhythmia, heart block, atrial fibrillation. (3) Severe respiratory disease. (4) Child-Pugh Class B or higher liver disease. 5.Other Conditions: (1) Long-term (>3 months within the past 1 year) use of analgesics or antimuscarinic agents. (2) Pregnancy or lactation. (3) Psychiatric disorders or cognitive impairment. (4) Morbid obesity (BMI >40 kg/m²). (5) Substance abuse. (6) Chronic pain history. (7) Co-existing other malignancies or life expectancy < 6 months. (8) Postoperative pathological diagnosis of muscle-invasive bladder cancer, or the need for immediate radical cystectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of moderate-to-severe CRBD (score >= 2);Bladder Spasm Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life measured by the EQ-5D-5L utility index;Frequency of diclofenac sodium suppository administration and cumulative dose;Adverse Events (AEs);Pethidine use frequency and cumulative dose; | — |
Countries
China
Contacts
Public ContactWeibin Hou
The Third Xiangya Hospital Central South University
Outcome results
None listed