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

NCT ID: NCT01942681

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-06-30

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Propiverine Hydrochloride Administration

Administration of Propiverine Hydrochloride for 12 weeks

Group Type: OTHER

Propiverine Hydrochloride

Intervention Type: DRUG

Administrate Propiverine Hydrochloride for 12 weeks

Interventions

Propiverine Hydrochloride

Administrate Propiverine Hydrochloride for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Bup-4

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shinshu University Hospital

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osamu Nishizawa, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shinshu University Hospital

Locations

Shinshu University Hospital

Matsumoto, Nagano, Japan

Countries

Japan

Other Identifiers

UMIN000011491

Identifier Type: OTHER

Identifier Source: secondary_id

TRIGU1309

Identifier Type: -

Identifier Source: org_study_id