Clinical trial NCT01942681: Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
Official title: Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: female
mixed urinary incontinence
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Shinshu University Hospital
First posted: 2013-09-16
Enrollment: 62
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Occurrence of incontinence
timeFrame: during a twelve-week treatment period
Secondary outcomes:
measure: The number of protective pad used
timeFrame: during a twelve-week treatment period
measure: Reduction ratio of the occurrence for incontinence
timeFrame: during a twelve-week treatment period
measure: ICIQ-Short Form(SF) scores
timeFrame: during a twelve-week treatment period
measure: I-QOL scores
timeFrame: during a twelve-week treatment period
measure: IPSS-QOL scores
timeFrame: during a twelve-week treatment period
measure: IPSS symptom scores
timeFrame: during a twelve-week treatment period
measure: OABSS symptom scores
timeFrame: during a twelve-week treatment period
measure: Blood pressure
timeFrame: during a twelve-week treatment period
measure: Pulse rate
timeFrame: during a twelve-week treatment period
measure: Safety assessment
timeFrame: during a twelve-week treatment period
Other outcomes:
measure: Maximum urethral closure pressure
timeFrame: during a twelve-week treatment period
measure: Functional profile length
timeFrame: during a twelve-week treatment period
Locations:
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
Study officials:
affiliation: Shinshu University Hospital
name: Osamu Nishizawa, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: