search
Back to results

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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urodynamic Stress Incontinence focused on measuring Pad test, Test-retest reliability

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 23, 2019
    Last Updated
    September 26, 2019
    Sponsor
    National Taiwan University Hospital
    search

    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

    Learn more about this trial

    Test-retest Reliability of 20-minute Pad Test

    We'll reach out to this number within 24 hrs