UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011491
Receipt number R000013445
Scientific Title Multi-institution study on efficacy and safety of Propiverine Hydrochloride for female patients with urge and stress urinary incontinence
Date of disclosure of the study information 2013/09/01
Last modified on 2018/01/13 13:19:35

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Basic information

Public title

Multi-institution study on efficacy and safety of Propiverine Hydrochloride for female patients with urge and stress urinary incontinence

Acronym

Female patients with uRgE and Stress urinary incontinence study of Propiverine Hydrochloride (FRESH)

Scientific Title

Multi-institution study on efficacy and safety of Propiverine Hydrochloride for female patients with urge and stress urinary incontinence

Scientific Title:Acronym

Female patients with uRgE and Stress urinary incontinence study of Propiverine Hydrochloride (FRESH)

Region

Japan


Condition

Condition

mixed urinary incontinence

Classification by specialty

Obstetrics and Gynecology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Propiverine Hydrochloride for female patients with mixed urinary incontinence.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the occurrence of incontinence in 1 week

Key secondary outcomes

the frequency of micturitions in 1 week
the occurrence of episodes of urgency without incontinence in 1 week
the number of protective pad used in 1 week
the reduction ratio of the occurrance of incontinence
QOL score (ICIQ-SF, I-QOL, IPSS-QOL)
symptom score(IPSS, OABSS)
response rate, blood pressure
pulse rate, residual urine volume

safety assessment


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

Administration of Propiverine Hydrochloride for 12 weeks

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 with mixed urinary incontinence (SUI)
2)Patients having symptoms of urinary incontinence for at least 3 months
3)Patients having at least one episode of urge urinary incontinence per week and 3 episodes of stress urinary incontinence per week in a bladder diary.
4)20 years old or older
5)Patients who meet all the following criteria in ICIQ-SF
1)"2-3 times or more in one week" was selected at Q1.
2)"Small or more" was selected at Q2.
3)"Leak at the time of cough or snooze or "leak at the time of exercise" was selected at Q4.
6)Less than 100 mL of residual urine volume
7)Written informed consent

Key exclusion criteria

1) Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract
2) Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis)
3) Patients with advanced lower urinary tract obstruction or urinary retention
4) Patients without urinary sensation
5) Patients with overflow incontinence
6) Patients with history or complications of pelvic organ prolapse
7) Patients with pyloric, duodenal or intestinal obstruction
8) Patients with gastric or intestinal atony
9) Patients with angle-closure glaucoma
10) Patients with myasthenia gravis
11) Patients with severe heart disease
12) Patients with severe constipation
13) Patients with dementia, who are not able to complete the questionnaires
14) Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine
15) Patients with history of surgery that affect urination such as TOT or TVT
16) Women who are pregnant, lactating, potentially pregnant or willing to get pregnant
17) Patients with previous surgery of the abdomen and pelvis or radiation within 6 months
18) Patients who started pelvic floor muscle exercise within 3 months
19) Patients who took Propiverine Hydrochloride or other similar medicine within 2 weeks before entry
20) Judged as being unsuitable for the trial by physician.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Nishizawa

Organization

Shinshu University Hospital

Division name

Urology

Zip code


Address

Asahi 3-1-1 Matsumoto city, 390-8621, Japan

TEL

0263-37-266

Email

onishiz@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomonori Minagawa

Organization

Shinshu University Hospital

Division name

Urology

Zip code


Address

Asahi 3-1-1 Matsumoto city, 390-8621, Japan

TEL

0263-37-2661

Homepage URL


Email

minagawat@shinshu-u.ac.jp


Sponsor or person

Institute

Foundation for Biomedical Research and Innovation

Institute

Department

Personal name



Funding Source

Organization

TAIHO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

信州大学 他


Other administrative information

Date of disclosure of the study information

2013 Year 09 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

Completed

Date of protocol fixation

2013 Year 07 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2015 Year 06 Month 30 Day

Date of closure to data entry

2015 Year 09 Month 30 Day

Date trial data considered complete

2015 Year 10 Month 31 Day

Date analysis concluded

2016 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 08 Month 15 Day

Last modified on

2018 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013445


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name