Antimuscarinic Treatment for Female Patients With Overact... | NCT01819168

Studies
Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing

NCT01819168

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Overactive Bladder Syndrome

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Apr 2016Actual

First Submitted Date

Mar 21, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bladder diary	To clarity any difference of reduction in the episodes of nocturia between these two groups.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Frequency and Urgency	To clarity any difference of reduction in the episodes of urinary frequency and urgency between these two groups.	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics & Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

We will perform a retrospective study to review the data of bladder diary, urodynamic studies and clinical data of patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics & Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan