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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Propiverine Hydrochloride
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring female, mixed urinary incontinence

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shinshu University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Propiverine Hydrochloride Administration

Arm Description

Administration of Propiverine Hydrochloride for 12 weeks

Outcomes

Primary Outcome Measures

Occurrence of incontinence
Change in occurrence of incontinence during a twelve-week treatment

Secondary Outcome Measures

The number of protective pad used
Change in the number of protective pad used 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
ICIQ-Short Form(SF) scores
Change in ICIQ-SF scores during a twelve-week treatment period
I-QOL scores
Change in I-QOL scores during a twelve-week treatment period
IPSS-QOL scores
Change in IPSS-QOL scores during a twelve-week treatment period
IPSS symptom scores
Change in IPSS symptom scores during a twelve-week treatment period
OABSS symptom scores
Change in OABSS symptom scores during a twelve-week treatment period
Blood pressure
Change in blood pressure during a twelve-week treatment period
Pulse rate
Change in pulse rate during a twelve-week treatment period
Safety assessment
The occurrence of adverse events during a twelve-week treatment period

Full Information

First Posted
August 29, 2013
Last Updated
July 14, 2015
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Shinshu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01942681
Brief Title
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
Acronym
FRESH
Official Title
Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Shinshu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
female, mixed urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propiverine Hydrochloride Administration
Arm Type
Other
Arm Description
Administration of Propiverine Hydrochloride for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Propiverine Hydrochloride
Other Intervention Name(s)
Bup-4
Intervention Description
Administrate Propiverine Hydrochloride for 12 weeks
Primary Outcome Measure Information:
Title
Occurrence of incontinence
Description
Change in occurrence of incontinence during a twelve-week treatment
Time Frame
during a twelve-week treatment period
Secondary Outcome Measure Information:
Title
The number of protective pad used
Description
Change in the number of protective pad used during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
Reduction ratio of the occurrence for incontinence
Description
Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
ICIQ-Short Form(SF) scores
Description
Change in ICIQ-SF scores during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
I-QOL scores
Description
Change in I-QOL scores during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
IPSS-QOL scores
Description
Change in IPSS-QOL scores during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
IPSS symptom scores
Description
Change in IPSS symptom scores during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
OABSS symptom scores
Description
Change in OABSS symptom scores during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
Blood pressure
Description
Change in blood pressure during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
Pulse rate
Description
Change in pulse rate during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
Safety assessment
Description
The occurrence of adverse events during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Other Pre-specified Outcome Measures:
Title
Maximum urethral closure pressure
Description
Change in maximum urethral closure pressure during a twelve-week treatment period
Time Frame
during a twelve-week treatment period
Title
Functional profile length
Description
Change in functional profile length during a twelve-week treatment period
Time Frame
during a twelve-week treatment period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Nishizawa, M.D., Ph.D.
Organizational Affiliation
Shinshu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan

12. IPD Sharing Statement

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

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