Test-retest Reliability of 20-minute Pad Test
Primary Purpose
Urodynamic Stress Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
20-minute pad test
Sponsored by
About this trial
This is an interventional diagnostic trial for Urodynamic Stress Incontinence focused on measuring Pad test, Test-retest reliability
Eligibility Criteria
Inclusion Criteria:
- Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS)
Exclusion Criteria:
- SUI but not USI
- Urinary tract infection
- Pelvic inflammation or malignancy
- Long term urinary catheterization
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study population
Arm Description
Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study.
Outcomes
Primary Outcome Measures
20-minute pad test
The pad weight or 20-minute pad test
Secondary Outcome Measures
Full Information
NCT ID
NCT04109157
First Posted
September 23, 2019
Last Updated
September 26, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04109157
Brief Title
Test-retest Reliability of 20-minute Pad Test
Official Title
Test-retest Reliability of 20-minute Pad Test Infused With Strong-desire Amount of Water In Bladder in Women With Urodynamic Stress Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2007 (Actual)
Primary Completion Date
December 31, 2010 (Actual)
Study Completion Date
December 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In our department, we performed a 20-minute pad test since 2005. The 20-minute pad test uses 250 mL of sterile water instilled directly into an empty bladder with a catheter rather than relying on walking for 30 minutes at the beginning of a one-hour pad test. We previously reported that 20-minute pad test has better sensitivity than the one-hour pad test in women with stress urinary incontinence (SUI). Due to the different bladder capacity in each patient, we tried to infuse strong-desire (SD) amounts of water that can more precisely reflect the full bladder capacity in each patient. We found an even better sensitivity when the 20-minute pad test was infused with SD amount of water in women with SUI compared with infusion with 250 mL of water in the bladder.
As to short-term pad test, previous studies had some concerned about the reliability and reproducibility. Thus, undertaking our previous two studies, we want to evaluate the test-retest reliability of the 20-minute pad test infused with SD amount of water in bladder in women with SUI.
Detailed Description
Between August 2007 and December 2010, a total of 89 women with SUI were recruited. Of them, 67 (75%) women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study. Our 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage. Each woman underwent a complete UDS before pad test, including uroflowmetry, filling (with a rate of 60mL H2O/min of 35℃ distilled water) and voiding cystometry, and stress urethral pressure profile using a two-way NO.7 French flexible Foley catheter with the SD amount in the bladder. The retest twenty-minute pad test infused with SD amount water in bladder was performed within one week after first pad test. The activities that the patients underwent were the same in test and retest 20-minute pad tests. USI was diagnosed if involuntary urine leakage was noted during filling cystometry, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. Detrusor overactivity (DO) was diagnosed if involuntary detrusor contraction occurred during filling cystometry. The exclusion criteria included no obvious USI, clinically significant urinary tract infection (UTI), and chronic pelvic inflammation. The procedures and study purpose were completely explained to the participants with fully informed consent.
A multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston, Tex) was used. All terminology conformed to the standards recommended by the ICS and Urodynamic Society. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid inter-observer variability.
STATA software (Version 11.0; Stata Corp, College Station, TX, USA) was used for statistical analyses. Spearman rank-correlation coefficient and intraclass correlation coefficient were tested for correlation and reliability of the test and retest results. The Wilcoxon signed rank test was tested for the difference of the test and retest. A p value of less than 0.05 was considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urodynamic Stress Incontinence
Keywords
Pad test, Test-retest reliability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study population
Arm Type
Other
Arm Description
Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS) and enrolled for analysis in this study.
Intervention Type
Diagnostic Test
Intervention Name(s)
20-minute pad test
Intervention Description
Our 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage.
Primary Outcome Measure Information:
Title
20-minute pad test
Description
The pad weight or 20-minute pad test
Time Frame
One week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who had fulfilled the standardization of terminology of lower urinary function from ICS were diagnosed as urodynamic stress incontinence (USI) after urodynamic study (UDS)
Exclusion Criteria:
SUI but not USI
Urinary tract infection
Pelvic inflammation or malignancy
Long term urinary catheterization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6112488
Citation
Sutherst J, Brown M, Shawer M. Assessing the severity of urinary incontinence in women by weighing perineal pads. Lancet. 1981 May 23;1(8230):1128-30. doi: 10.1016/s0140-6736(81)92299-6.
Results Reference
background
PubMed Identifier
3201169
Citation
Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardisation of terminology of lower urinary tract function. The International Continence Society Committee on Standardisation of Terminology. Scand J Urol Nephrol Suppl. 1988;114:5-19. No abstract available.
Results Reference
background
PubMed Identifier
11857671
Citation
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Results Reference
background
PubMed Identifier
25744851
Citation
Ferreira CH, Bo K. The Pad Test for urinary incontinence in women. J Physiother. 2015 Apr;61(2):98. doi: 10.1016/j.jphys.2014.12.001. Epub 2015 Mar 3. No abstract available.
Results Reference
background
PubMed Identifier
17070349
Citation
Wu WY, Sheu BC, Lin HH. Comparison of 20-minute pad test versus 1-hour pad test in women with stress urinary incontinence. Urology. 2006 Oct;68(4):764-8. doi: 10.1016/j.urology.2006.04.018.
Results Reference
background
PubMed Identifier
23797972
Citation
Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.
Results Reference
background
PubMed Identifier
3388665
Citation
Lose G, Rosenkilde P, Gammelgaard J, Schroeder T. Pad-weighing test performed with standardized bladder volume. Urology. 1988 Jul;32(1):78-80. doi: 10.1016/0090-4295(88)90462-1.
Results Reference
background
PubMed Identifier
17540494
Citation
Wu WY, Sheu BC, Lin HH. Twenty-minute pad test: comparison of infusion of 250 ml of water with strong-desire amount in the bladder in women with stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):121-5. doi: 10.1016/j.ejogrb.2007.02.030. Epub 2007 May 30.
Results Reference
background
PubMed Identifier
11281474
Citation
Simons AM, Yoong WC, Buckland S, Moore KH. Inadequate repeatability of the one-hour pad test: the need for a new incontinence outcome measure. BJOG. 2001 Mar;108(3):315-9. doi: 10.1111/j.1471-0528.2001.00069.x.
Results Reference
background
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Test-retest Reliability of 20-minute Pad Test
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