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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Propiverine Hydrochloride Administration	Propiverine Hydrochloride	Administration of Propiverine Hydrochloride for 12 weeks

Primary Outcome Measures

Name	Time	Method
Occurrence of incontinence	during a twelve-week treatment period	Change in occurrence of incontinence during a twelve-week treatment

Secondary Outcome Measures

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

Recruitment & Eligibility