NCT01627145

Brief Summary

Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

2.4 years

First QC Date

June 21, 2012

Last Update Submit

November 14, 2012

Conditions

Overactive Bladder Syndrome

Keywords

overactive bladder syndromederusor overactivityurodynamic studiesbladder oversensitivity

Outcome Measures

Primary Outcomes (1)

  • The percentage of normalized urodynamic pattern after treatment

    12 weeks

Secondary Outcomes (1)

  • The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence

    48 months

Study Arms (1)

antimuscariniz drug

EXPERIMENTAL
Drug: Solifenacin

Interventions

SolifenacinDRUG

Solifenacin 5 mg qd,

antimuscariniz drug

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients within 18 years old to 99 years old with overactive bladder syndrome

You may not qualify if:

  • unwilling or unable to perform testing procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No 8, Chung-Shan South Road,

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ho-Hsiung Lin, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

TW(1)