UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026714
Receipt number R000024393
Scientific Title RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.
Date of disclosure of the study information 2017/03/27
Last modified on 2017/03/27 12:27:01

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Basic information

Public title

RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.

Acronym

RCT study of bladder instillation therapy for refractory interstitial cystitis.

Scientific Title

RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.

Scientific Title:Acronym

RCT study of bladder instillation therapy for refractory interstitial cystitis.

Region

Japan


Condition

Condition

Interstitial cystitis

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of bladder instillation therapy of heparin alone and combination of heparin and alkalized lidocaine in patients with interstitial cystitis. Also to assess the safety and efficacy of maintenance therapy with heparin or heparin and alkalized lidocaine combination.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III


Assessment

Primary outcomes

Global response assessment at 3rd month of maintenance therapeutic phase.

Key secondary outcomes

1. daily urinary frequency, nocturnal urinary frequency, average voided volume per urination.
2. Maximum urine flow rate, average urine flow rate, residual urine volume.
3. O'Leary & Sant's symptom score, problem score, visual analogue scale for pain, overactive bladder symptom score, international prostate symptom score
4. adverse event

at 6,12 the weeks after enrollment and 3rd,6th ,9th months at maintenance therapy.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treated with vesical instillation with heparin and alkalized lidocaine. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.

Interventions/Control_2

Treated with vesical instillation with heparin alone. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.

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

1. Patients over 20 years old with interstitial cystitis who were diagnosed by hydrodistension at present institution.
2. Patients who are willing to participate in the study after written informed consent.
3. Patients with both OSSI and OSPI scores more than 6points and visual analogue scale for pain more than 3 points.
4. Patients who are able to be treated at outpatient.

Key exclusion criteria

1. Patients who cannot fulfill the above inclusion criteria.
2. Patients with gross hematuria.
3. Patients with lidocaine allergy.
4. Patients who are regarded not suitable for this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Nomiya

Organization

Mitsui Memorial Hospital

Division name

Department of Urology

Zip code


Address

1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643

TEL

03-3862-9111

Email

anomiya-jua@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Nomiya

Organization

Mitsui Memorial Hospital

Division name

Department of Urology

Zip code


Address

1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643

TEL

03-3862-9111

Homepage URL


Email

anomiya-jua@umin.ac.jp


Sponsor or person

Institute

Department of Urology, Mitsui Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

Mitsui Memorial Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

社会福祉法人 三井記念病院 (東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 27 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

2014 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 27 Day

Last modified on

2017 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024393


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name