UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044106 |
|---|---|
| Receipt number | R000050366 |
| Scientific Title | Single Intradetrusor Injection Of Autologous Adipose-derived Stem Cells In Parkinson's Disease Patients With Overactive Bladder: A Pilot Study |
| Date of disclosure of the study information | 2021/05/05 |
| Last modified on | 2021/05/05 07:20:54 |
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Basic information
Public title
Single Intradetrusor Injection Of Autologous Adipose-derived Stem Cells In Parkinson's Disease Patients With Overactive Bladder
Acronym
SIIADSCPDOAB
Scientific Title
Single Intradetrusor Injection Of Autologous Adipose-derived Stem Cells In Parkinson's Disease Patients With Overactive Bladder: A Pilot Study
Scientific Title:Acronym
SIIADSCPDOABPS
Region
| Asia(except Japan) |
Condition
Condition
Overactive Bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety of intradetrusor adipose stem cells (ADSC) injections and their effect on PD-related OAB symptoms
Basic objectives2
Others
Basic objectives -Others
Assess bladder diary measures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change from baseline in OAB symptom score (OABSS) and the overactive bladder questionnaire short form (OAB-q SF) score in patients with Parkinson's disease
Key secondary outcomes
The secondary outcomes were the change from baseline in the mean number of micturitions per 24 h, the mean number of urgency episodes per24 h, the mean number of urgency incontinence episodes per 24 h, and the mean number of nocturia episodes per night as recorded on a 3-day bladder diary at baseline and 6 months later. Safety assessments included any reported adverse events
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment group receiving a single injection into the detrusor muscle of 10ml of ADSC solution
Interventions/Control_2
Placebo group receiving single injection into the detrusor muscle 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
| 71 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with a clinical diagnosis of PD according to UK Brain Bank Criteria, patients age between 40 and 70 years, have a stable dose of antiparkinsonian drugs 8 weeks before study entry, stage 1 to 3 on modified Hoehn and Yahr scale, patients had an urgency score more or equa than 2 and a total score more or equal than 3 of the OAB symptom score (OABSS)
Key exclusion criteria
patients with secondary parkinsonism syndromes, patients with polyuria with a daily urine volume more than 3000 mL, patients taking anticholinergic medications for OAB symptoms, history of benign prostatic hypertrophy, patients with stress urinary incontinence or urinary tract infection.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Mohamad |
| Middle name | |
| Last name | Abou Chakra |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
0096171613732
mohamedabouchakra@hotmail.com
Public contact
Name of contact person
| 1st name | Mohamad |
| Middle name | |
| Last name | Moussa |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
00961964412
Homepage URL
mohamadamoussa@hotmail.com
Sponsor or person
Institute
Al Zahraa Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Al Zahraa Hospital
Address
Beirut, Lebanon
Tel
009611851040ext3364
uroprog@gmail
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
| 2021 | Year | 05 | Month | 05 | 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
12
Results
Patients received single intradetrusor ADSC injection experienced significant improvements in all bladder diary measures. Patients satisfaction with treatment, assessed by the mean of OAB-q SF total HRQL score significantly improved and symptom bother significantly decreased
Results date posted
| 2021 | Year | 05 | Month | 05 | 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
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 05 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050366
