UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of trans-obturator tape operation for male patients with severe stress incontinence
Title of the study (Brief title)	TOT study for male incontinence
Region	Japan

Condition
Condition	stress urinary incontinence
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the utility and safety of trans-obturator tape operation for iatrogenic male stress urinary incontinence
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Degree of improvement the scores of the IPSS, ICIQSF, and SF36 at 1 and 3 months after operation, compared with those at baseline
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Operation of insertion of a tape via obturator foramen
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1)Stress urinary incontinence, assessed by ICIQSF 2)PS 2 or less 3)6 months or more after operation, causing stress incontinence 4)Lack of urethral stricture, assessed by urethro-cystoscopy 5)ALPP 65cmH2O or less 6)Obtainment of written informed consent
Key exclusion criteria	1)Severe infectious disease, or other uncontrollable diseases 2)Active urothelial or prostate cancer 3)Past history of irradiation to bulbous urethra
Target sample size	30

Research contact person
Name of lead principal investigator	Osamu Ogawa
Organization	Kyoto University, graduate school of medicine
Division name	Urology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3337
Email	ogawao@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Koji Yoshimura
Organization	Kyoto University, graduate school of medicine
Division name	Urology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3337
Homepage URL
Email	ky7527@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University, Graduate School of Medicine, Department of Urology
Institute
Department

Funding Source
Organization	none
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	2013 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2009 Year 01 Month 28 Day
Anticipated trial start date	2009 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 20 Day
Last modified on	2016 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013494