UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040981 |
|---|---|
| Receipt number | R000046794 |
| Scientific Title | Efficacy of propiverine hydrochloride for urinary incontinence afterlaparoscopic radical prostatectomy |
| Date of disclosure of the study information | 2020/07/02 |
| Last modified on | 2020/07/02 13:30:22 |
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Basic information
Public title
Efficacy of propiverine hydrochloride for urinary incontinence afterlaparoscopic radical prostatectomy
Acronym
Propiverine HCl after prostatectomy
Scientific Title
Efficacy of propiverine hydrochloride for urinary incontinence afterlaparoscopic radical prostatectomy
Scientific Title:Acronym
Propiverine HCl after prostatectomy
Region
| Japan |
Condition
Condition
Efficacy of propiverine hydrochloride for urinary incontinence after robot-assisted or laparoscopic radical prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main aim of this study was to clarify the efficacy of propiverine hydrochloride after radical prostatectomy with laparoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the pad-test negative rate at 6 months postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in the treatment group received propiverine hydrochloride at a dose of 20 mg/day for 6 months.
Interventions/Control_2
Patients in the control group did not received.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who underwent RALP or LRP at our hospital from April 2013 to December 2017 and who experienced postoperative urinary incontinence, defined as pad gain over 1 g on 1-hour pad test.
Key exclusion criteria
Patients were excluded if they had neurogenic bladder dysfunction, overactive bladder, SUI, urinary tract infection, urethral stricture, glaucoma, severe cardiac disease, renal dysfunction, and/or hepatic dysfunction. Patients were also excluded if they received radiation therapy and/or oral treatment with anticholinergic agents, antidepressants.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Kojiro |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University Hospital
Division name
Department of Urology and Renal Transplantation
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
0958197340
ohba-k@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University Hospital
Division name
Department of Urology and Renal Transplantation
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
+81958197340
Homepage URL
ohba-k@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
Department of Urology and Renal Transplantation
Tel
0958197340
ohba-k@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
104
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046794
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
