Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

August 24, 2017 updated by: Medstar Health Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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?"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Icon reusable underwear
Device: Disposable pad
Standard market disposable pad
PLACEBO_COMPARATOR: Disposable pad
Device: Icon resuable underwear
Reusable incontinence underwear

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Product Performance Questionnaire
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Lee Richter, MedStar Washington Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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