Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

Conditions
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Reusable Underwear, Urinary Incontinence, Dispoable Pad

Intervention / Treatment
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* Device: Icon resuable underwear
* Device: Disposable pad


Participation Criteria
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Eligibility Criteria
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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?
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icon reusable underwear<br> | Device: Disposable pad<br>* Standard market disposable pad<br>|
| Placebo Comparator: Disposable pad<br> | Device: Icon resuable underwear<br>* Reusable incontinence underwear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence Quality of Life Questionnaire | Validated quality of life questionnaire | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Performance Questionnaire |  | 2 days |