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

Overview

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.

Full Title of Study: “Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Interventions

  • Drug: Propiverine Hydrochloride
    • Administrate Propiverine Hydrochloride for 12 weeks

Arms, Groups and Cohorts

  • Other: Propiverine Hydrochloride Administration
    • Administration of Propiverine Hydrochloride for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of incontinence
    • Time Frame: during a twelve-week treatment period
    • Change in occurrence of incontinence during a twelve-week treatment

Secondary Measures

  • 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
  • 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
  • ICIQ-Short Form(SF) scores
    • Time Frame: during a twelve-week treatment period
    • Change in ICIQ-SF scores 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
  • IPSS-QOL scores
    • Time Frame: during a twelve-week treatment period
    • Change in IPSS-QOL scores 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
  • OABSS symptom scores
    • Time Frame: during a twelve-week treatment period
    • Change in OABSS symptom scores 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
  • Pulse rate
    • Time Frame: during a twelve-week treatment period
    • Change in pulse rate 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
  • Collaborator
    • Shinshu University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Osamu Nishizawa, M.D., Ph.D., Principal Investigator, Shinshu University Hospital

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