FemPulse Therapy for Overactive Bladder in Women (EVANESCE-OAB)

FemPulse

Status: Unknown

Conditions: Urinary Bladder, Overactive

Treatments: Device: FemPulse System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03784170

CIP-002

Details and patient eligibility

About

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Full description

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Enrollment: 21 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females 21 years or older with a diagnosis of Overactive Bladder
• If of reproductive age, must use a reliable form of contraception

Exclusion criteria

• Pregnant, was recently pregnant or is trying to conceive
• Has a metal pelvic implant or any electrically active implanted medical device
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months
• Has a significant heart condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups

Treatment

Experimental group

Description:

FemPulse System at one device setting

Treatment:

Device: FemPulse System

Control

Sham Comparator group

Description:

FemPulse System at a different device setting

Treatment:

Device: FemPulse System