UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institution study on efficacy and safety of Propiverine Hydrochloride for female patients with urge and stress urinary incontinence
Title of the study (Brief title)	Female patients with uRgE and Stress urinary incontinence study of Propiverine Hydrochloride (FRESH)
Region	Japan

Condition
Condition	mixed urinary incontinence
Classification by specialty	Obsterics 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	Osamu Nishizawa
Organization	Shinshu University Hospital
Division name	Urology
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	Tomonori Minagawa
Organization	Shinshu University Hospital
Division name	Urology
Address	Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL	0263-37-2661
Homepage URL
Email	minagawat@shinshu-u.ac.jp

Sponsor
Institute	Foundation for Biomedical Research and Innovation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013445