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Evaluation of the Efficacy of Mirabilon and Solifenacin for Preventing Catheter-Related Bladder Discomfort After Transurethral Resection Surgery: a Prospective, Randomized, Placebo-Controlled Study

Evaluation of the Efficacy of Mirabilon and Solifenacin for Preventing Catheter-Related Bladder Discomfort After Transurethral Resection Surgery: a Prospective, Randomized, Placebo-Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028650
Enrollment
Unknown
Registered
2019-12-29
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Catheter Related Bladder Discomfort

Interventions

M group:Mirabegron 50mg
S group:Solifenacine
C group:Nil

Sponsors

Capital Medical University, Beijing Chaoyang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: a. Patients participate voluntarily. They are able to understand and comply with the scheme, as well as sign an informed consent form; b. The age of patient is between 18 and 75 years old, regardless of sex; c. Patients with indwelling catheter for more than 3 days after transurethral resection

Exclusion criteria

Exclusion criteria: 1. People with major diseases, including patients who may confuse the effectiveness of the evaluation (those who have participated in or are in the process of participating in other clinical trials within 3 months); 2. Patients with diseases with taboos in the use of anticholinergic drugs (such as urine retention, angle-closure glaucoma (untreated, uncontrolled intraocular pressure), paralytic intestinal obstruction, etc.); 3. Patients with obvious abnormal liver and kidney function (ALT, AST) are 2 times higher than the normal value, and the (Cr) of renal function is 1.5 times higher than the normal value. 4. Patients also use drugs that may affect detrusor activity, including anticholinergic drugs and tricyclic antidepressants. 5. Patients also use drugs that may affect the metabolism of the tested drugs, including fluoxetine and macrolide antibiotics. 6. Patients who consume too much caffeine (drinking more than five cups of coffee, tea or cola a day); 7. Those who have a history of alcohol or drug abuse in the last year; 8. People who are allergic to anticholinergic drugs 9. Patietns with systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100 mmHg; 10. Patients with congenital or acquired prolonged QT interval. 11. Patients with Double J stent; 12. Pregnant women, lactating women, and patients planning to become pregnant; 13. Patients who are determined by the researchers to be unsuitable.

Design outcomes

Primary

MeasureTime frame
Overactive Bladder Symptoms Score;Catheter-Related Bladder Discomfort;

Countries

China

Contacts

Public ContactPeng Zhang

Capital Medical University, Beijing Chaoyang Hospital

seabottlezp@126.com+86 13611046169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026