UMIN-CTR Clinical Trial

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