Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

M

MedStar Health

Status

Completed

Conditions

Reusable Underwear, Urinary Incontinence, Dispoable Pad

Treatments

Device: Icon resuable underwear
Device: Disposable pad

Study type

Interventional

Funder types

Other

Identifiers

NCT03263676
2016-042

Details and patient eligibility

About

This is a randomized cross over trial to compare quality of life and product performance between Icon reusable underwear versus standard disposable pad in patients with mild to moderate urinary incontinence.

Full description

Urinary incontinence is estimated to affect approximately 1/5 of all women in the United States. Multiple studies have compared effectiveness, cost-effectiveness and comfort of a variety absorbent products but most of the current data compares daily disposable insert pads. Icon reusable underwear is a new product on the market for light incontinence (25-30mL daily). The primary objective of this randomized cross over trial is to compare quality of life and patient comfort and to determine patient preference using Icon reusable underwear versus standard incontinence pad in the management of urinary incontinence. The secondary objective is to compare the cost-effectiveness of ICON underwear to disposable pads. Women with small to moderate urinary incontinence to use either ICON underwear or pads for two days and then crossed over to use other product for two days. The primary outcome measures were Incontinence Quality of Life Instrument 3 (I-QOL) and Product Performance Questionnaire 4 (PPQ) after use of each product. A sample size of 70 was calculated to detect a difference of 10.0 in the I-QOL to achieve a power of 80% with a significance level of 0.05 and to account for a 20% attrition.

Enrollment

70 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients who are at least 18yo
  • Mild to moderate urinary incontinence, defined as a response "small" or "moderate" amount to the ICIQ-SF question - "How much do you leak?"

Exclusion criteria

  • Active urinary tract infection
  • Fecal incontinence, defined as a response "large" amount to the ICIQ-SF question - "How much do you leak?"

Trial design

70 participants in 2 patient groups, including a placebo group

Icon reusable underwear
Experimental group
Treatment:
Device: Disposable pad
Disposable pad
Placebo Comparator group
Treatment:
Device: Icon resuable underwear

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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