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Completed

NCT Number: NCT01942681

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shinshu University Hospital

Matsumoto, Nagano, 390-8621, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propiverine hydrochloride

Drug

Administrate Propiverine Hydrochloride for 12 weeks

Other names: Bup-4

Primary outcomes

  1. Occurrence of incontinence

    Time frame: during a twelve-week treatment period

    Change in occurrence of incontinence during a twelve-week treatment

Secondary outcomes

  1. 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

  2. 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

  3. ICIQ-Short Form(SF) scores

    Time frame: during a twelve-week treatment period

    Change in ICIQ-SF scores during a twelve-week treatment period

  4. I-QOL scores

    Time frame: during a twelve-week treatment period

    Change in I-QOL scores during a twelve-week treatment period

  5. IPSS-QOL scores

    Time frame: during a twelve-week treatment period

    Change in IPSS-QOL scores during a twelve-week treatment period

  6. IPSS symptom scores

    Time frame: during a twelve-week treatment period

    Change in IPSS symptom scores during a twelve-week treatment period

  7. OABSS symptom scores

    Time frame: during a twelve-week treatment period

    Change in OABSS symptom scores during a twelve-week treatment period

  8. Blood pressure

    Time frame: during a twelve-week treatment period

    Change in blood pressure during a twelve-week treatment period

  9. Pulse rate

    Time frame: during a twelve-week treatment period

    Change in pulse rate during a twelve-week treatment period

  10. Safety assessment

    Time frame: during a twelve-week treatment period

    The occurrence of adverse events during a twelve-week treatment period

Other outcomes

  1. Maximum urethral closure pressure

    Time frame: during a twelve-week treatment period

    Change in maximum urethral closure pressure during a twelve-week treatment period

  2. Functional profile length

    Time frame: during a twelve-week treatment period

    Change in functional profile length during a twelve-week treatment period

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Shinshu University Hospital

Registry information

Official study title

Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence

Acronym: FRESH

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2013
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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