UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Heparin-lidocaine intravesical injection therapy for refractory interstitial cystitis
Title of the study (Brief title)	Heparin-lidocaine intravesical injection therapy for 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 the heparin-lidocaine intravesical therapy for the patients with interstitial cystitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary frequency
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	Medicine
Interventions/Control_1	heparin-lidocaine intravesical 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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Recurrence of interstitial cystitis was observed in the cystoscopy
Key exclusion criteria	1. Patients with active urinary tract infection, urinary tract hemorrhage, urinary tract malignancy 2. Patients with systolic blood pressure of 200 mmHg or more or less than 89 mmHg and diastolic blood pressure of 80 mmHg or more 3. Patients with serious liver and kidney dysfunction 4. Patients with drug hypersensitivity such as allergies 5. Pregnant women and patients who may be pregnant or breast-feeding patients 6. Patients who participated in other clinical studies within 4 months 7. Patients whose research managers judged inappropriate as research subjects
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuyoshi Miyata
Organization	Nagasaki University Hospital
Division name	Department of Urology and Renal transplantation
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7340
Email	int.doc.miya@m3.dion.ne.jp

Public contact
Name of contact person	Tomohiro Matsuo
Organization	Nagasaki University Hospital
Division name	Department of Urology and Renal transplantation
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7340
Homepage URL
Email	tomo1228@nagasaki-u.ac.jp

Sponsor
Institute	Department of Urology and Renal transplantation, Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Department of Urology and Renal transplantation, Nagasaki University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 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 06 Month 25 Day
Last modified on	2017 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031980