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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044106
Receipt No. 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

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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
Email 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
Email mohamadamoussa@hotmail.com

Sponsor
Institute Al Zahraa Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050366

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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