NCT01942681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

1.7 years

First QC Date

August 29, 2013

Last Update Submit

July 14, 2015

Conditions

Urinary Incontinence

Keywords

femalemixed urinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Occurrence of incontinence

    Change in occurrence of incontinence during a twelve-week treatment

    during a twelve-week treatment period

Secondary Outcomes (10)

  • The number of protective pad used

    during a twelve-week treatment period

  • Reduction ratio of the occurrence for incontinence

    during a twelve-week treatment period

  • ICIQ-Short Form(SF) scores

    during a twelve-week treatment period

  • I-QOL scores

    during a twelve-week treatment period

  • IPSS-QOL scores

    during a twelve-week treatment period

  • +5 more secondary outcomes

Other Outcomes (2)

  • Maximum urethral closure pressure

    during a twelve-week treatment period

  • Functional profile length

    during a twelve-week treatment period

Study Arms (1)

Propiverine Hydrochloride Administration

OTHER

Administration of Propiverine Hydrochloride for 12 weeks

Drug: Propiverine Hydrochloride

Interventions

Propiverine HydrochlorideDRUG

Administrate Propiverine Hydrochloride for 12 weeks

Also known as: Bup-4
Propiverine Hydrochloride Administration

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with mixed urinary incontinence (MUI)
  • Patients having symptoms of urinary incontinence for at least 3 months
  • 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.
  • years old or older
  • 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.
  • Less than 100mL of residual urine volume
  • Written informed consent.

You may not qualify if:

  • Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract
  • Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis)
  • Patients with advanced lower urinary tract obstruction or urinary retention
  • Patients without urinary sensation
  • Patients with overflow incontinence
  • Patients with history or complications of pelvic organ prolapse
  • Patients with pyloric, duodenal or intestinal obstruction
  • Patients with gastric or intestinal atony
  • Patients with angle-closure glaucoma
  • Patients with myasthenia gravis
  • Patients with severe heart disease
  • Patients with severe constipation
  • Patients with dementia who are not able to complete the questionnaires
  • Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine
  • Patients with history of surgery that affect urination such as Trans-Obturator Tape（TOT）or Tension-free Vaginal Tape（TVT）
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinshu University Hospital

Matsumoto, Nagano, 390-8621, Japan

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

propiverine

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Osamu Nishizawa, M.D., Ph.D.

    Shinshu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 16, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

JP(1)