Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride (FRESH)

July 14, 2015 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Shinshu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients with mixed urinary incontinence (MUI)
  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 4 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 sneeze" or "leak at the time of exercise" was selected at Q4.
  6. Less than 100mL of residual urine volume
  7. Written informed consent.

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 Trans-Obturator Tape（TOT）or Tension-free Vaginal Tape（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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Propiverine Hydrochloride Administration
Administration of Propiverine Hydrochloride for 12 weeks
Drug: Propiverine Hydrochloride
Administrate Propiverine Hydrochloride for 12 weeks
Other Names:
  • Bup-4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of incontinence
Time Frame: during a twelve-week treatment period
Change in occurrence of incontinence during a twelve-week treatment
during a twelve-week treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of protective pad used
Time Frame: during a twelve-week treatment period
Change in the number of protective pad used during a twelve-week treatment period
during a twelve-week treatment period
Reduction ratio of the occurrence for incontinence
Time Frame: during a twelve-week treatment period
Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period
during a twelve-week treatment period
ICIQ-Short Form(SF) scores
Time Frame: during a twelve-week treatment period
Change in ICIQ-SF scores during a twelve-week treatment period
during a twelve-week treatment period
I-QOL scores
Time Frame: during a twelve-week treatment period
Change in I-QOL scores during a twelve-week treatment period
during a twelve-week treatment period
IPSS-QOL scores
Time Frame: during a twelve-week treatment period
Change in IPSS-QOL scores during a twelve-week treatment period
during a twelve-week treatment period
IPSS symptom scores
Time Frame: during a twelve-week treatment period
Change in IPSS symptom scores during a twelve-week treatment period
during a twelve-week treatment period
OABSS symptom scores
Time Frame: during a twelve-week treatment period
Change in OABSS symptom scores during a twelve-week treatment period
during a twelve-week treatment period
Blood pressure
Time Frame: during a twelve-week treatment period
Change in blood pressure during a twelve-week treatment period
during a twelve-week treatment period
Pulse rate
Time Frame: during a twelve-week treatment period
Change in pulse rate during a twelve-week treatment period
during a twelve-week treatment period
Safety assessment
Time Frame: during a twelve-week treatment period
The occurrence of adverse events during a twelve-week treatment period
during a twelve-week treatment period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum urethral closure pressure
Time Frame: during a twelve-week treatment period
Change in maximum urethral closure pressure during a twelve-week treatment period
during a twelve-week treatment period
Functional profile length
Time Frame: during a twelve-week treatment period
Change in functional profile length during a twelve-week treatment period
during a twelve-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shinshu University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Osamu Nishizawa, M.D., Ph.D., Shinshu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIGU1309
  • UMIN000011491 (OTHER: UMIN Clinical Trials Registry (UMIN-CTR))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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