UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006116 |
|---|---|
| Receipt number | R000007233 |
| Scientific Title | Periurethral injection of autologous adipose-derived stem cells from liposuction for the treatment of stress urinary incontinence |
| Date of disclosure of the study information | 2011/08/04 |
| Last modified on | 2018/12/12 12:21:41 |
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Basic information
Public title
Periurethral injection of autologous adipose-derived stem cells from liposuction for the treatment of stress urinary incontinence
Acronym
Autologous adipose-derived stem cells for the treatment of stress urinary
Scientific Title
Periurethral injection of autologous adipose-derived stem cells from liposuction for the treatment of stress urinary incontinence
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Momokazu Gotoh |
Organization
NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
UROLOGY
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
UROLOGY
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2011 | Year | 03 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007233
