UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027494
Receipt number R000031504
Scientific Title Intravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis
Date of disclosure of the study information 2017/05/25
Last modified on 2019/05/27 13:39:16

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Basic information

Public title

Intravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis

Acronym

Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis

Scientific Title

Intravesical administration of Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis

Scientific Title:Acronym

Dimethyl sulfoxide(DMSO) for patients with Interstitial cystitis

Region

Japan


Condition

Condition

Interstitial cystitis

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of intravesical Dimethyl sulfoxide(DMSO) treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

IC symptom score

Key secondary outcomes

Frequency-volume chart


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

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

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravesical DMSO administration (50%, 50ml),2weeks every, 8 times

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with interstitial cystitis who did not have enough efficacy by bladder hydrodistention

Key exclusion criteria

Patients who did not agree this trial

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Otsuka

Organization

Hamamatsu University School of Medicine

Division name

Urology

Zip code

431-3192

Address

1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

TEL

053-435-2306

Email

otsuka@hama-med.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Otsuka

Organization

Hamamatsu University School of Medicine

Division name

Urology

Zip code

431-3192

Address

1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

TEL

053-435-2306

Homepage URL


Email

otsuka@hama-med.ac.jp


Sponsor or person

Institute

Department of Urology, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Hamamatsu University School of Medicine

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

Institutional Review Board of Hamamatsu University School of Medicine

Address

1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

Tel

053-435-2111

Email

rinri@hama-med.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

浜松医科大学医学部附属病院(静岡県)


Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 25 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

27

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

Completed

Date of protocol fixation

2004 Year 06 Month 18 Day

Date of IRB

2004 Year 07 Month 20 Day

Anticipated trial start date

2004 Year 07 Month 20 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 25 Day

Last modified on

2019 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031504


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name