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

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

Status: Completed

Conditions: Urinary Incontinence

Treatments: Drug: Propiverine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01942681

TRIGU1309

UMIN000011491 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Propiverine Hydrochloride Administration

Other group

Description:

Administration of Propiverine Hydrochloride for 12 weeks

Treatment:

Drug: Propiverine Hydrochloride