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Test-retest Reliability of 20-minute Pad Test

NCT04109157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-09-30

No results posted yet for this study

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.

Conditions

  • Urodynamic Stress Incontinence

Interventions

DIAGNOSTIC_TEST

20-minute pad test

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ho-Hsiung Lin, PhD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-01
Primary Completion
2010-12-31
Completion
2010-12-31
FDA Device
Yes

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Read the full study record

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View NCT04109157 on ClinicalTrials.gov