UMIN-CTR Clinical Trial

Basic information
Public title	Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence
Acronym	Clinical Trial of ADRCs for the Treatment of Male Stress Urinary Incontinence (ADRESU study)
Scientific Title	Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence
Scientific Title:Acronym	Clinical Trial of ADRCs for the Treatment of Male Stress Urinary Incontinence (ADRESU study)
Region	Japan

Condition
Condition	Stress Urinary Incontinence
Classification by specialty	Surgery in general Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Rate of patients at 52 weeks with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Key secondary outcomes	1) Rate of patients at each evaluation time point with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test 2) Urine leakage volume at each evaluation time point by 24-hour pad test 3) Rate of patients at each evaluation time point with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline 4) Number of incontinence episodes per day at each evaluation time point 5) Number of pads used per day at each evaluation time point 6) QOL score (ICIQ-SF and KHQ) at each evaluation time point 7) Patient overall satisfaction at each evaluation time point 8) Urodynamic parameters (MUCP, FPL and ALPP) at each evaluation time point 9) Blood flow at the injection site measured by transrectal ultrasonography at each evaluation time point 10) Injection site evaluated by pelvis MRI scan at each evaluation time point

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	Device,equipment Maneuver Other
Interventions/Control_1	Injection of autologous adipose derived regenerative cells and adipose tissue
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	Not applicable
Gender	Male
Key inclusion criteria	1) Males with stress urinary incontinence with insufficient effect by behavioral therapy or pharmacotherapy persisting more than 1 year after either of the following surgical procedure: ･Patients with symptoms after radical prostatectomy for localized prostate cancer and currently without relapse/metastasis, and PSA level less than 0.1 ng/mL for over 1 year ･Patients with symptoms after transurethral prostatectomy or laser prostatectomy for prostatic hyperplasia, and PSA level less than 4.0 ng/mL for over 1 year 2) Age of 20 or above 3) Mild to moderate urinary incontinence on the 24-hour pad test 4) Patients who can keep a bladder diary in a satisfactory manner 5) Patients who are willing and able to give signed consent
Key exclusion criteria	1) Concurrent with any other types of urinary incontinence than stress urinary incontinence 2) History of urinary or reproductive surgery within 6 months prior to the consent 3) History of behavioral therapy or pharmacotherapy within 3 months prior to the consent 4) Concurrent with diabetes insipidus 5) History of radiotherapy in the lower urinary tract 6) History of ADRCs treatment for stress urinary incontinence 7) History of any type of cell therapy within 6 months prior to the consent 8) Participation in any other clinical trial within 3 months prior to the consent 9) Concurrent with lower urinary tract obstruction 10) Concurrent with urolithiasis, urinary tract infection or interstitial cystitis 11) History of recurrent urinary tract infection 12) History of malignant neoplasm within 5 years prior to the consent or a suspicion of it (Patients with a history of radical prostatectomy for localized prostate cancer without relapse/metastasis over 1 year may be enrolled) 13) Life expectancy of less than 1 year 14) Any other patients whom the trial investigator deemed ineligible to this study
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Momokazu Middle name Last name Gotoh
Organization	Nagoya University Hospital
Division name	Department of Urology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2985
Email	gotoh@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Shinobu Middle name Last name Shimizu
Organization	Nagoya University Hospital
Division name	ADRESU Clinical Trial Management Office
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-1956
Homepage URL
Email	adrcs@c-ctd.co.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Cytori Therapeutics, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Hospital Institutional review board
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-1958
Email	center@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02529865
Org. issuing International ID_1	the U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋大学医学部附属病院（愛知県）、金沢大学附属病院（石川県）、信州大学医学部附属病院（長野県）、獨協医科大学病院（栃木県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Related information
URL releasing protocol	https://bmcurol.biomedcentral.com/articles/10.1186/s12894-017-0282-7
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	45
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	2015 Year 04 Month 13 Day
Date of IRB	2015 Year 04 Month 21 Day
Anticipated trial start date	2015 Year 08 Month 20 Day
Last follow-up date	2019 Year 03 Month 07 Day
Date of closure to data entry	2019 Year 06 Month 17 Day
Date trial data considered complete	2019 Year 06 Month 21 Day
Date analysis concluded	2019 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 14 Day
Last modified on	2019 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020539