NCT01876186

Brief Summary

To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

June 10, 2013

Last Update Submit

July 5, 2015

Conditions

Overactive Bladder Syndrome

Keywords

antimuscarinic treatmenturodynamic studiesnerve growth factor

Outcome Measures

Primary Outcomes (1)

  • The rate of normalized urodynamic findings

    The rate of normalized urodynamic finding after antimuscarinics

    6 months

Secondary Outcomes (3)

  • The cure rate of overactive bladder

    24 weeks

  • The recurrence rate of overactive bladder

    2.5 years

  • The difference of urine nerve growth factor level

    24 weeks

Study Arms (2)

Solifenacin for 12 weeks group

EXPERIMENTAL

Solifenacin (5 mg qd) for 12 weeks

Drug: Solifenacin for 12 weeks

Solifenacin for 24 weeks group

ACTIVE COMPARATOR

Solifenacin (5 mg qd) for 24 weeks

Drug: Solifenacin for 24 weeks

Interventions

Solifenacin for 12 weeksDRUG

Solifenacin 5 mg one a day for 12 weeks

Also known as: Vesicare
Solifenacin for 12 weeks group
Solifenacin for 24 weeksDRUG

Solifenacin 5 mg once a day for 24 weeks

Also known as: Vesicare
Solifenacin for 24 weeks group

Eligibility Criteria

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

You may qualify if:

  • Women who have overactive bladder syndrome

You may not qualify if:

  • Women who are less than 20 year-old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ho-Hsiung Lin, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Hsiung Lin, MD, PhD

CONTACT

+886-2-23123456hhlin@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

TW(1)