Trial record 4 of 123 for:    Open Studies | "Urinary Incontinence"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Translational Research Informatics Center, Kobe, Hyogo, Japan
Sponsor:
Collaborator:
Shinshu University Hospital
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01942681
First received: August 29, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Urinary Incontinence
Drug: Propiverine Hydrochloride

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Occurrence of incontinence [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in occurrence of incontinence during a twelve-week treatment


Secondary Outcome Measures:
  • The number of protective pad used [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in the number of protective pad used during a twelve-week treatment period

  • Reduction ratio of the occurrence for incontinence [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period

  • ICIQ-Short Form(SF) scores [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in ICIQ-SF scores during a twelve-week treatment period

  • I-QOL scores [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in I-QOL scores during a twelve-week treatment period

  • IPSS-QOL scores [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in IPSS-QOL scores during a twelve-week treatment period

  • IPSS symptom scores [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in IPSS symptom scores during a twelve-week treatment period

  • OABSS symptom scores [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in OABSS symptom scores during a twelve-week treatment period

  • Blood pressure [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in blood pressure during a twelve-week treatment period

  • Pulse rate [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in pulse rate during a twelve-week treatment period

  • Safety assessment [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: Yes ]
    The occurrence of adverse events during a twelve-week treatment period


Other Outcome Measures:
  • Maximum urethral closure pressure [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in maximum urethral closure pressure during a twelve-week treatment period

  • Functional profile length [ Time Frame: during a twelve-week treatment period ] [ Designated as safety issue: No ]
    Change in functional profile length during a twelve-week treatment period


Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Propiverine Hydrochloride Administration
Administration of Propiverine Hydrochloride for 12 weeks
Drug: Propiverine Hydrochloride
Administrate Propiverine Hydrochloride for 12 weeks
Other Name: Bup-4

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942681

Contacts
Contact: Tomonori Minagawa, M.D., Ph.D. 81-263-37-2661 minagawat@shinshu-u.ac.jp
Contact: Koichi Yamashiro 81-78-304-6804 FRESH@tri-kobe.org

Locations
Japan
Shinshu University Hospital Recruiting
Matsumoto, Nagano, Japan, 390-8621
Contact: Tomonori Minagawa, M.D., Ph.D.    81-263-37-2661    minagawat@shinshu-u.ac.jp   
Principal Investigator: Osamu Nishizawa         
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Shinshu University Hospital
Investigators
Principal Investigator: Osamu Nishizawa, M.D., Ph.D. Shinshu University Hospital
  More Information

No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01942681     History of Changes
Other Study ID Numbers: TRIGU1309, UMIN000011491
Study First Received: August 29, 2013
Last Updated: March 5, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
female
mixed urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Propiverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014