Urinary IncontinenceFRESHNCT01942681
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
A study testing Propiverine Hydrochloride in people with Urinary Incontinence, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Propiverine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with mixed urinary incontinence (MUI)
- Patients having symptoms of urinary incontinence for at least 3 months
- Patients having at least one episode of urge urinary incontinence per week and 4 episodes of stress urinary incontinence per week in a bladder diary.
- 20 years old or older
- 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 sneeze" or "leak at the time of exercise" was selected at Q4.
- Less than 100mL of residual urine volume
- Written informed consent.
Who cannot join
- Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract
- Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis)
- Patients with advanced lower urinary tract obstruction or urinary retention
- Patients without urinary sensation
- Patients with overflow incontinence
- Patients with history or complications of pelvic organ prolapse
Show all 20Show fewer
- Patients with pyloric, duodenal or intestinal obstruction
- Patients with gastric or intestinal atony
- Patients with angle-closure glaucoma
- Patients with myasthenia gravis
- Patients with severe heart disease
- Patients with severe constipation
- Patients with dementia who are not able to complete the questionnaires
- Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine
- Patients with history of surgery that affect urination such as Trans-Obturator Tape（TOT）or Tension-free Vaginal Tape（TVT）
- Women who are pregnant, lactating, potentially pregnant or willing to get pregnant
- Patients with previous surgery of the abdomen and pelvis or radiation within 6 months
- Patients who started pelvic floor muscle exercise within 3 months
- Patients who took Propiverine Hydrochloride or other similar medicine within 2 weeks before entry
- Judged as being unsuitable for the trial by physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence
This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.
- Conditions
- Urinary Incontinence
- Being tested
- Propiverine Hydrochloride
- Keywords
- female, mixed urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propiverine HydrochlorideDrug
Also called Bup-4
Administrate Propiverine Hydrochloride for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Propiverine Hydrochloride Administration | Other | Administration of Propiverine Hydrochloride for 12 weeks Receives: Drug: Propiverine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of incontinence
Change in occurrence of incontinence during a twelve-week treatment
Measured: during a twelve-week treatment period
Secondary outcomes (10)
The number of protective pad used
Change in the number of protective pad used during a twelve-week treatment period
Measured: during a twelve-week treatment period
Reduction ratio of the occurrence for incontinence
Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period
Measured: during a twelve-week treatment period
ICIQ-Short Form(SF) scores
Change in ICIQ-SF scores during a twelve-week treatment period
Measured: during a twelve-week treatment period
I-QOL scores
Change in I-QOL scores during a twelve-week treatment period
Measured: during a twelve-week treatment period
IPSS-QOL scores
Change in IPSS-QOL scores during a twelve-week treatment period
Measured: during a twelve-week treatment period
IPSS symptom scores
Change in IPSS symptom scores during a twelve-week treatment period
Measured: during a twelve-week treatment period
OABSS symptom scores
Change in OABSS symptom scores during a twelve-week treatment period
Measured: during a twelve-week treatment period
Blood pressure
Change in blood pressure during a twelve-week treatment period
Measured: during a twelve-week treatment period
Pulse rate
Change in pulse rate during a twelve-week treatment period
Measured: during a twelve-week treatment period
Safety assessment
The occurrence of adverse events during a twelve-week treatment period
Measured: during a twelve-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Shinshu University Hospital
- Responsible party
- Sponsor
- Investigators
- Osamu Nishizawa, M.D., Ph.D., Principal investigator, Shinshu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942681
- Sponsor's protocol ID
- TRIGU1309
- Other IDs
- UMIN000011491
- Acronym
- FRESH
- Status last verified
- Jul 2015
- First submitted
- 29 Aug 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01942681
- Acronym / sponsor ID
- FRESH / TRIGU1309
- Conditions
- Urinary Incontinence
- Keywords
- female, mixed urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Shinshu University Hospital
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propiverine Hydrochloride Administration | Other | Drug: Propiverine HydrochlorideAdministration of Propiverine Hydrochloride for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients with mixed urinary incontinence (MUI)
- Patients having symptoms of urinary incontinence for at least 3 months
- Patients having at least one episode of urge urinary incontinence per week and 4 episodes of stress urinary incontinence per week in a bladder diary.
- 20 years old or older
- 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 sneeze" or "leak at the time of exercise" was selected at Q4.
Key exclusion criteria (20 listed)
- Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract
- Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis)
- Patients with advanced lower urinary tract obstruction or urinary retention
- Patients without urinary sensation
- Patients with overflow incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propiverine HydrochlorideAlso: Bup-4Administrate Propiverine Hydrochloride for 12 weeks | Drug | Propiverine Hydrochloride Administration |
Primary outcome
Occurrence of incontinence
Time frame: during a twelve-week treatment period
Change in occurrence of incontinence during a twelve-week treatment
10 secondary outcomes
The number of protective pad used
Time frame: during a twelve-week treatment period
Reduction ratio of the occurrence for incontinence
Time frame: during a twelve-week treatment period
ICIQ-Short Form(SF) scores
Time frame: during a twelve-week treatment period
I-QOL scores
Time frame: during a twelve-week treatment period
IPSS-QOL scores
Time frame: during a twelve-week treatment period
IPSS symptom scores
Time frame: during a twelve-week treatment period
OABSS symptom scores
Time frame: during a twelve-week treatment period
Blood pressure
Time frame: during a twelve-week treatment period
Pulse rate
Time frame: during a twelve-week treatment period
Safety assessment
Time frame: during a twelve-week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osamu Nishizawa, M.D., Ph.D. principal investigator
Shinshu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propiverine Hydrochloride in people with Urinary Incontinence, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of incontinence (time frame: during a twelve-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.