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

Urinary Incontinence Clinical Trial

— FRESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942681
• Other study ID #: TRIGU1309
• Secondary ID: UMIN000011491
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: July 14, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• Propiverine Hydrochloride
Administrate Propiverine Hydrochloride for 12 weeks

Locations

Country	Name	City	State
Japan	Shinshu University Hospital	Matsumoto	Nagano

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Shinshu University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum urethral closure pressure	Change in maximum urethral closure pressure during a twelve-week treatment period	during a twelve-week treatment period	No
Other	Functional profile length	Change in functional profile length during a twelve-week treatment period	during a twelve-week treatment period	No
Primary	Occurrence of incontinence	Change in occurrence of incontinence during a twelve-week treatment	during a twelve-week treatment period	No
Secondary	The number of protective pad used	Change in the number of protective pad used during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	Reduction ratio of the occurrence for incontinence	Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	ICIQ-Short Form(SF) scores	Change in ICIQ-SF scores during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	I-QOL scores	Change in I-QOL scores during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	IPSS-QOL scores	Change in IPSS-QOL scores during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	IPSS symptom scores	Change in IPSS symptom scores during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	OABSS symptom scores	Change in OABSS symptom scores during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	Blood pressure	Change in blood pressure during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	Pulse rate	Change in pulse rate during a twelve-week treatment period	during a twelve-week treatment period	No
Secondary	Safety assessment	The occurrence of adverse events during a twelve-week treatment period	during a twelve-week treatment period	Yes