UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence after Radical Prostatectomy for prostate cancner
Title of the study (Brief title)	A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence
Region	Japan

Condition
Condition	post-prostatectomy urinary incontinence
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of usefulness of penis clamping device for post-prostatectomy urinary incontinence
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient satisfaction
Key secondary outcomes	complication

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	male post-prostatectomy urinary incontinence, 20 or more age, with consent
Key exclusion criteria	no urinary incontinence non-compliance
Target sample size	10

Research contact person
Name of lead principal investigator	Yuji MAEDA
Organization	Matto Central Hospital
Division name	Urology
Address	Kuramitsu 3-8, Hakusan, Ishikawa
TEL	076-275-2222
Email	y-maeda@mattohp.com

Public contact
Name of contact person	Yuji MAEDA
Organization	Matto Central Hospital
Division name	Urology
Address	Kuramitsu 3-8, Hakusan, Ishikawa
TEL	076-275-2222
Homepage URL
Email	y-maeda@mattohp.com

Sponsor
Institute	Matto Central Hospital
Institute
Department

Funding Source
Organization	Matto Central Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 30 Day
Date trial data considered complete	2018 Year 11 Month 04 Day
Date analysis concluded	2018 Year 11 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2018 Year 01 Month 11 Day
Last modified on	2018 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035125