UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012512
Receipt number R000014645
Scientific Title Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.
Date of disclosure of the study information 2015/04/01
Last modified on 2013/12/06 19:42:56

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Basic information

Public title

Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.

Acronym

Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.

Scientific Title

Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.

Scientific Title:Acronym

Evaluation of the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.

Region

Japan


Condition

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the effect onset with Propiverine hydrochloride(BUP-4) in Female Patients diagnosed as overactive bladder.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

change of frequency of urination in 24 hours

Key secondary outcomes

change of urinary urgency in 24 hours, change of urinary incontinence in 24 hours, change of OABSS score, change of KHQ score, Residual urine volume, adverse event


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

Propiverine hydrochloride(BUP-4) 20mg will be orally administered once day after breakfast after observation period(2days)

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

Female

Key inclusion criteria

1) Female Patients diagnosed as overactive bladder.
2) 20 years old or more patients,
3) Residual urine volume is less than 50mL

Key exclusion criteria

1) Patients with bladder stone, urethral calculus, interstitial cystitis
2) Patients with endometriosis required for surgery and pelvic organ prolapse
3) Patients with history of treatment OAB within 2 months
4) Patients with treatment for cancer
5) Patients with lower urinary tract symptom
6) Patients with symptomatic urinary tract infection
7) Patients with polyuria (>=3000mL /day)
8) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled hypertension)
9) Patients with angle-closure glaucoma
10) Patients with severe heart dysfunction, renal dysfunction, liver dysfunction
11) Women who are capable of pregnancy, intend to get pregnant
12) Pregnant or lactating women
13) Judged ineligible based on physicians' decision

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yousuke Tsukinaga

Organization

Maruyama Memorial General Hospital

Division name

Department of Urology

Zip code


Address

Hon-tyo 1981, Iwatsuki-ku, Saitama-shi, Saitama 339-8521, Japan

TEL

048-757-3511

Email

tsuky1979@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Washino

Organization

Jichi Saitama Medical Center

Division name

Department of Urology

Zip code


Address

Amanuma-tyo 1-847, Oomiya-ku, Saitama-shi, Saitama 330-8503, Japan

TEL

048-647-2111

Homepage URL


Email

suwajiisan@jichi.ac.jp


Sponsor or person

Institute

Saitama Continence Conference

Institute

Department

Personal name



Funding Source

Organization

Saitama Continence Conference

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 01 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

2013 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 01 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

2013 Year 12 Month 06 Day

Last modified on

2013 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014645


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name