Evaluation Trial of Handheld Urinal for Adult Use

Binding Sciences

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Device: RS - WP06

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04897932

BSL BHT IRAS 291714

Details and patient eligibility

About

Usability and efficacy evaluation of a prototype handheld urinal for adult use

Full description

28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion criteria

• Suffers only from stress UI

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Adult nocturia

Active Comparator group

Description:

Use of device over 28 days

Treatment:

Device: RS - WP06

Adult urge urinary incontinence

Active Comparator group

Description:

Use of device over 28 days

Treatment:

Device: RS - WP06

Adult frequency urinary incontinence

Active Comparator group

Description:

Use of device over 28 days

Treatment:

Device: RS - WP06

Adult functional incontinence

Active Comparator group

Description:

Use of device over 28 days

Treatment:

Device: RS - WP06