UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047336 |
|---|---|
| Receipt number | R000053985 |
| Scientific Title | Single Intrasphincteric Injection Of Autologous Adipose-derived Stem Cells To Treat Stress Urinary Incontinence After Radical Prostatectomy |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/03/31 02:28:29 |
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Basic information
Public title
Single Intrasphincteric Injection Of Autologous Adipose-derived Stem Cells To Treat Stress Urinary Incontinence After Radical Prostatectomy: A Pilot Study
Acronym
ADSCTTSUI
Scientific Title
Single Intrasphincteric Injection Of Autologous Adipose-derived Stem Cells To Treat Stress Urinary Incontinence After Radical Prostatectomy
Scientific Title:Acronym
SCTTSUI
Region
| Asia(except Japan) |
Condition
Condition
Stress urinary incontinence after radical prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety and efficacy of intrasphincteric Adipose derived Stem Cells (ADSC) injections to treat stress urinary incontinence post radical prostatectomy.
Basic objectives2
Others
Basic objectives -Others
The secondary outcomes were the change from baseline in the mean of ICIQ-UI SF score
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
The primary outcomes of our study were the change from baseline in the mean of the 24-h pad weight test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
treatment group (received a single injection into the urethral rhabdosphincter 10ml of ADSC solution)
Interventions/Control_2
placebo group (single injection into the urethral rhabdosphincter of 10ml of normal saline).
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
patients with an stress urinary incontinence for > 18 months after surgery, localized low to intermediate-risk prostate cancer before surgery, have no biochemical recurrence at study enrollment, the patient had no adjuvant chemotherapy or radiotherapy, all patients had pelvic floor training for > 6 months. All patients had office cystoscopy before entering the study to exclude bladder neck contracture or urethral stenosis
Key exclusion criteria
patients taking anticholinergic medications for overactive bladder symptoms or taking a diuretic for heart failure, patients with urinary tract infection, patients with any neurologic disease that may affect bladder function
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mohamad |
| Middle name | |
| Last name | Abou Chakra |
Organization
Lebanese University
Division name
Stem Cell Center
Zip code
1108
Address
Beirut, Lebanon
TEL
+96171613732
mohamedabouchakra@hotmail.com
Public contact
Name of contact person
| 1st name | Mohamad |
| Middle name | |
| Last name | Moussa |
Organization
Lebanese Univeristy
Division name
Stem Cell Center
Zip code
1108
Address
Beirut, Lebanon
TEL
+9613964412
Homepage URL
mohamadamoussa@hotmail.com
Sponsor or person
Institute
Al Zahraa Hospital, Beirut, Lebanon
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Al Zahraa Hospital
Address
Beirut, Lebaon
Tel
+961851773 ext 3064
uroprog@gmail.com
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
Al Zahraa Hospital (LEBANON)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | 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
10
Results
Findings from this study provide preliminary evidence in support of the safety and potential clinical utility of intrasphincteric ADSCs injections for the treatment of stress urinary incontinence post radical prostatectomy
Results date posted
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2018 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 17 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053985
