NCT01776593

Brief Summary

To identify the bladder diary parameters that are best correlated to VSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

January 18, 2013

Last Update Submit

January 23, 2013

Conditions

Bladder DiaryUrodynamic Studies

Keywords

bladder capacity; bladder diary; bladder oversensitivity; lower urinary tract symptoms

Outcome Measures

Primary Outcomes (1)

  • To identify the bladder diary parameter that is best correlated to the volume at strong desire to void of filling cystometry.

    To identify which bladder diary parameter that is best correlated to the volume at strong desire to void of filling cystometry. Thus, that bladder diary parameter may be used as a surrogate for the volume of strong desire to void of filling cystometry and without the need of urodynamic studies.

    1 week

Study Arms (1)

Lower urinary tract symptoms

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients with lower urinary tract symptoms

You may qualify if:

  • Female patients with lower urinary tract symptoms who had underwent urodynamic studies

You may not qualify if:

  • Patients without data of bladder diary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Ho-Hsiung Lin

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 28, 2013

Study Start

April 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

TW(1)