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
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
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
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
