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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Drug: Propiverine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Propiverine Hydrochloride Administration; Administration of Propiverine Hydrochloride for 12 weeks	Drug: Propiverine Hydrochloride; Administrate Propiverine Hydrochloride for 12 weeks; Other Names: Bup-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of incontinence	Change in occurrence of incontinence during a twelve-week treatment	during a twelve-week treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
ICIQ-Short Form(SF) scores	Change in ICIQ-SF scores during a twelve-week treatment period	during a twelve-week treatment period
I-QOL scores	Change in I-QOL scores during a twelve-week treatment period	during a twelve-week treatment period
IPSS-QOL scores	Change in IPSS-QOL scores during a twelve-week treatment period	during a twelve-week treatment period
IPSS symptom scores	Change in IPSS symptom scores during a twelve-week treatment period	during a twelve-week treatment period
OABSS symptom scores	Change in OABSS symptom scores during a twelve-week treatment period	during a twelve-week treatment period
Blood pressure	Change in blood pressure during a twelve-week treatment period	during a twelve-week treatment period
Pulse rate	Change in pulse rate during a twelve-week treatment period	during a twelve-week treatment period
Safety assessment	The occurrence of adverse events during a twelve-week treatment period	during a twelve-week treatment period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum urethral closure pressure	Change in maximum urethral closure pressure during a twelve-week treatment period	during a twelve-week treatment period
Functional profile length	Change in functional profile length during a twelve-week treatment period	during a twelve-week treatment period

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Shinshu University Hospital
• Investigators: Principal Investigator: Osamu Nishizawa, M.D., Ph.D., Shinshu University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (ESTIMATE): September 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: female; mixed urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Propiverine
• Other Study ID Numbers: TRIGU1309; UMIN000011491 (OTHER: UMIN Clinical Trials Registry (UMIN-CTR))