Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

Reusable Underwear, Urinary Incontinence, Dispoable Pad Clinical Trial

Official title:

Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263676
• Other study ID #: 2016-042
• Status: Completed
• Phase: N/A
• First received: August 24, 2017
• Last updated: August 24, 2017
• Start date: July 1, 2016
• Est. completion date: April 1, 2017

Study information

• Verified date: August 2017
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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?"

Related Conditions & MeSH terms

• Enuresis
• Reusable Underwear, Urinary Incontinence, Dispoable Pad
• Urinary Incontinence

Intervention

Device:
• Icon resuable underwear
Reusable incontinence underwear
• Disposable pad
Standard market disposable pad

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence Quality of Life Questionnaire	Validated quality of life questionnaire	2 days
Secondary	Product Performance Questionnaire		2 days