NCT02126618

Brief Summary

The aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of SUI. Besides, the above results may be used for further refinement of the amount of water infusion used for the 20-minute pad test.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

2.1 years

First QC Date

April 28, 2014

Last Update Submit

July 5, 2015

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower urinary tract symptomsurodynamic studiesdiuresis

Outcome Measures

Primary Outcomes (1)

  • Estimation of natural diuresis during pad testing

    The aim of this study is to estimate the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of SUI.

    7 years

Study Arms (1)

women with lower urinary tract symptoms

Eligibility Criteria

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

Women with lower urinary tract symptoms and underwent urodynamic testing

You may qualify if:

  • More than 20-year-old woman who with stress urinary incontinence (SUI).
  • We will review the clinical data, urodynamics, pad weight and bladder diary of patients who receiving urodynamic studies and 20-minute pad test in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014.

You may not qualify if:

  • \< 20 year old female

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

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lin Ho-Hsiung, MD, PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

April 30, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

TW(1)