UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Periurethral injection of autologous adipose-derived stem cells from liposuction for the treatment of stress urinary incontinence
Title of the study (Brief title)	Autologous adipose-derived stem cells for the treatment of stress urinary
Region	Japan

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

Objectives
Narrative objectives1	To study on efficacy and safety of periurethral injection of autologous adipose-derived stem cells from liposuction for the treatment of stress urinary incontinence
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of improvement of SUI Evaluation of safety
Key secondary outcomes	Evaluation of imaging including blood flow

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	Medicine
Interventions/Control_1	Periurethral injection of autologous adipose-derived stem cells from liposuction for the treatment of stress urinary incontinence
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 intractable postprostatectomy SUI with the radicality 2 SUI by transurethral resection of prostate by electric or laser divices 3 Female true SUI
Key exclusion criteria	no informed consent from the patient One's reemaining days less than 1 year by the complication History of maniglancy less than 5 years or the possibility The possibiliy of recurrence of prostatic cancer Bacterial or viral(HCV, HB, Wa-R,HIV)infection Severe renal or liver damage Severe hematopoietic disease or anemia The possibility of pregnancy Inappropriate judgement by attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	Momokazu Gotoh
Organization	NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name	UROLOGY
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
TEL
Email

Public contact
Name of contact person
Organization	NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name	UROLOGY
Address
TEL
Homepage URL
Email

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

Funding Source
Organization	Nagoya University 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	2011 Year 08 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 14 Day
Anticipated trial start date	2011 Year 06 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 04 Day
Last modified on	2018 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007233