UMIN-CTR Clinical Trial

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
Email	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
Email	mohamadamoussa@hotmail.com

Sponsor
Institute	Al Zahraa Hospital, Beirut, Lebanon
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053985