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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041660
Receipt No. R000047548
Scientific Title The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Date of disclosure of the study information 2020/09/04
Last modified on 2020/09/03

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Basic information
Public title The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Acronym The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Scientific Title The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Scientific Title:Acronym The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Region
Japan

Condition
Condition Refractory urinary incontinence
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the usefulness of SSP therapy in refractory urinary incontinence.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of change from baseline in total points on the Overactive Bladder Symptom Score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 SSP therapy
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with refractory urinary incontinence
Key exclusion criteria The women who are pregnant or who may be pregnant and so on
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Yamanishi
Organization Dokkyo Medical University Hospital
Division name Department of Urology, Continence Center
Zip code 321-0293
Address 880, Kitakobayashi, Mibu, Tochigi
TEL 0282-86-1111
Email yamanish@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Kanya
Middle name
Last name Kaga
Organization Dokkyo Medical University Hospital
Division name Department of Urology, Continence Center
Zip code 321-0293
Address 880, Kitakobayashi, Mibu, Tochigi
TEL 0282-86-1111
Homepage URL
Email k-kaga@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Self funding
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 Dokkyo Medical University Hospital
Address 880, Kitakobayashi, Mibu, Tochigi
Tel 0282-86-1111
Email k-kaga@dokkyomed.ac.jp

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
2020 Year 09 Month 04 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
Results
Results date posted
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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 04 Day
Last follow-up date
2020 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 03 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047548

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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