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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017901
Receipt No. R000020539
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
Date of disclosure of the study information 2015/07/01
Last modified on 2019/11/13

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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