UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017901 |
|---|---|
| Receipt number | 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 13:56:57 |
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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
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
adrcs@c-ctd.co.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020539
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