UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.
Title of the study (Brief title)	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	Akira Nomiya
Organization	Mitsui Memorial Hospital
Division name	Department of Urology
Address	1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643
TEL	03-3862-9111
Email	anomiya-jua@umin.ac.jp

Public contact
Name of contact person	Akira Nomiya
Organization	Mitsui Memorial Hospital
Division name	Department of Urology
Address	1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643
TEL	03-3862-9111
Homepage URL
Email	anomiya-jua@umin.ac.jp

Sponsor
Institute	Department of Urology, Mitsui Memorial Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024393