UMIN-CTR Clinical Trial

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
Email	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
Email	ohba-k@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046794