NCT03263676

Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Reusable Underwear, Urinary Incontinence, Dispoable Pad

Interventions

Type	Name	Description
DEVICE	Icon resuable underwear	Reusable incontinence underwear
DEVICE	Disposable pad	Standard market disposable pad

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2017-08-28
• Last updated: 2017-08-28