The Effect of Diuresis During 20-minute Pad Test on the Estimation of the Severity of Stress Urinary Incontinence

Lower Urinary Tract Symptoms Clinical Trial

Official title:

The Effect of Diuresis During 20-minute Pad Test on the Estimation of the Severity of Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126618
• Other study ID #: 201403054RIND
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: July 5, 2015
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: National Taiwan University Hospital
• Contact: Lin Ho-Hsiung, MD, PhD
• Phone: 886-2-23123456
• Email: hhlin[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Description:

Pad testing is an important method to evaluate the severity of women with stress urinary incontinence (SUI). The investigators had proved the superiority of the infusion of the strong desire amount while using 20-minute pad test for detecting SUI. However, a considerable volume of urine may be produced by natural diuresis during the course of 20-minute pad test with strong-desire amount infusion, and may cause bladder overdistension, more urine leakage and overestimate the severity of SUI. Thus, the aim of this study is to estimate of 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.

The investigators will review the clinical data of patients who receiving urodynamic studies in the Department of Obstetrics & Gynecology of National Taiwan University Hospital between January 2008 and March 2014. STATA 11.0 software will be used for statistical analysis.

The investigators will get the mean values of diuresis, and the factors affecting the amount of diuresis. Besides, the investigators can get the influence of diuresis on the accuracy of 20-minute pad test as a role of estimating the severity of SUI. The above data should be important for further refinement of 20-minute pad test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• < 20 year old female

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics & Gynecology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No