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

• Conditions: Lower Urinary Tract Symptoms

• Registration Number: NCT02126618
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-04-30
• Study Start: 2014-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-05
• Last Update Posted: 2015-07-07
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of natural diuresis during pad testing	7 years	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.

Trial Locations

Locations (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan