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CRIS문의

  • Status : Approved
    • First Submitted Date : 2019/01/03
    • Registered Date : 2019/04/15
    • Last Updated Date : 2019/02/12
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1. Background

Background Information
CRIS
Registration Number
KCT0003784 
Unique Protocol ID DAUHIRB-18-217 
Public/Brief Title Evaluate clinical efficacy and safety of Imidafenacin for recovering of continence after radical prostatectomy 
Scientific Title Study on urinary incontinence after curative prostatectomy for prostate cancer patients to evaluate urinary incontinence and safety using Imidafenacin twice a day  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol  
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Submitted pending

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number DAUHIRB-18-217 
Approval Date 2018-11-07 
Institutional Review Board  
Name Dong-A Uninversity Hospital IRB 
Address 26, Daesingongwon-ro, Seo-gu, Busan 
Telephone 051-240-2577 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Gyungtak Sung 
Title Professor 
Telephone +82-2-240-5446 
Affiliation Dong-A University Hospital 
Address 26, Daesingongwon-ro, Seo-gu, Busan 
Contact Person for Public Queries
Name Soodong Kim 
Title Professor 
Telephone +82-51-240-5446 
Affiliation Dong-A University Hospital 
Address 26, Daesingongwon-ro, Seo-gu, Busan 
Contact Person for Updating Information
Name Soodong Kim 
Title Professor 
Telephone +82-51-240-5446 
Affiliation Dong-A University Hospital 
Address 26, Daesingongwon-ro, Seo-gu, Busan 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-03-01 , Anticipated
Target Number of Participant 60
Primary Completion Date 2019-10-31 , Anticipated
Study Completion Date 2019-10-31 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Dong-A University Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-03-01 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Chong Kun Dang 
Organization Type Pharmaceutical Company  
Project ID DAUHIRB-18-217 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Dong-A University Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary The purpose of this study is to evaluate the effect of imidafenacin therapy, which is an anticholinergic agent, on the recovery of continence function after radical prostatectomy. Although two main causes of urinary incontinence (detrusor instability, intrinsic sphincter deficiency) may be considered for the treatment of α-adrenergic agonist and anticholinergic agents before surgical treatment, the research is insufficient. Imidafenacin (uritos®), a class of anticholinergic agents, has been used as a treatment for urinary frequency and overactive baldder (OAB). Huang et al. reported that Imidafenacin treated group had a significantly lower frequency of urgent urinary incontinence as compared to placebo group, but also improved urinary frequency and urgent urinary incontinence. Park et al. reported that 67 patients with OAB-related symptoms showed improvement in quality of life and improvement in the level of OAB compared to Propiverine-treated group.Based on results of these studies, we need a prospective study that evaluate recovery of long-term storage symptoms, increase of bladder volume, recovery of urethral smooth muscle tension and increase of urethral pressure, which can be expected with Imidafenacin. Therefore, this study is a randomized, patient-controlled clinical trial evaluating the efficacy of imidafenacin for the recovery of urinary frequency in patients with urinary incontinence after radical prostatectomy. If the urinary incontinence is confirmed after 2 to 4 weeks of follow-up in the outpatient clinic, the patient should be instructed to take the imidafenacin group and the control group (kegel exercise) before the radical prostatectomy. ) At a 1: 1 ratio, respectively. (IPSS), assessment of urinary incontinence (1 hr pad test, OAB-SS) and treatment status of prostate cancer (PSA) through questionnaires.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Prospective    
Target Number of Participant 60
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
imidafenacin group, control group 
Cohort/Group
Description
Imidafenacin group and control group were observed. Observations were made at 1, 3, and 6 months Depending on the timing of the observation, the incontinence rate was assessed using the OAB-SS questionnaire Assessment of voiding pattern is performed using IPSS (International Prostate Symptom Score) 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description Among patients who were diagnosed with prostate cancer and underwent radical prostatectomy, they did not take preoperative anticholinergic agents. After removal of Foley catheter, patients who had urinary incontinence at Visit 2 (2 to 4 weeks after surgery)  
Sampling Method The non-probability sampling method is used to select patients and the following conditions must be met. Patients who had urinary incontinence after Visit 2 (postoperative 2 to 4 weeks after removal of the Foley catheter) and those who did not take the anticoagulant prior to surgery were excluded. Signed and dated the Testee Consent Form confirming that the legal representative has been informed of the overall contents of the exam prior to enrollment and has the will and ability to complete the scheduled visit, treatment plan, laboratory test and other testing procedures.  
Condition(s)/Problem(s) * Diseases of The genitoruinary system
Rare Disease No
Inclusion
Criteria
Gender Male 
Age 40 Year ~ No Limit
Description 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  
Exclusion Criteria 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  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome In patients with urinary incontinence after radical prostatectomy, the rate of recovery of urinary incontinence between the anticholinergic group and control group 
Timepoint End to study date 
Primary Outcome(s) 2 
Outcome Evaluation of voiding pattern between imidafenacin group and control group in patients with urinary incontinence after radical prostatectomy 
Timepoint End of study date 
Secondary Outcome(s) 1 
Outcome Post prostatectomy incontinence 
Timepoint End of study date 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Yes 
Time of Sharing 2020.10
Way of Sharing Available on Request
(journal report)
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