Evaluate clinical efficacy and safety of Imidafenacin for recovering of continence after radical prostatectomy
- Conditions
- Neoplasms
- Registration Number
- KCT0003784
- Lead Sponsor
- Dong-A University Hospital
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
1) Patients diagnosed with prostate cancer and subjected to radical prostatectomy
2) Not taking anticholinergic drugs before surgery
3) After removal of the Foley catheter after surgery, at 2 to 4 weeks after surgery
4) If the subject has signed and dated the test subject agreement confirming that the information on the overall contents of the test has been provided prior to registration
5) You are willing and able to complete scheduled visits, treatment plans, laboratory tests, and other testing procedures
1) Prostate-proven prostate cancer was treated with radical prostatectomy but the histology was not adenocarcinoma
2) Neoadjuvant hormone therapy before radical prostatectomy.
3) 60 days after radical prostatectomy
4) Serious side effects after surgery
5) Patients with severe gastrointestinal disorders including addictive megacolon
6) Patients with myasthenia gravis
7) Patients with narrow angle glaucoma
8) Patients with severe renal disease
Patients with severe hepatic impairment (Child class C)
10) Patients who are hypersensitive to anticholinergic agents
11) Patients with genetic problems such as galactose intolerance, lactose dehydrogenase deficiency or glucose-galactose uptake disorder
12) Patients with uncontrolled diabetes
13) Patients with QT prolongation (QTc> 500 msec) on Electrocardiogram
14) If you are participating in other clinical trials
15) Other severe acute or chronic medical or mental conditions or laboratory abnormalities which, when deemed by the tester, would appear to result in an excessive risk of participation in the study or administration of the test drug, or that would make it inappropriate to participate in the study
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In patients with urinary incontinence after radical prostatectomy, the rate of recovery of urinary incontinence between the anticholinergic group and control group;Evaluation of voiding pattern between imidafenacin group and control group in patients with urinary incontinence after radical prostatectomy
- Secondary Outcome Measures
Name Time Method Post prostatectomy incontinence