FemPulse Therapy First-in-Human Experience

FemPulse

Status: Completed

Conditions: Urinary Bladder, Overactive

Treatments: Device: Sham Control; Device: Treament

Study type: Interventional

Funder types: Industry

Identifiers

NCT03874637

CIP-001

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 in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Enrollment: 15 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females ≥21 yrs with Overactive Bladder

Exclusion criteria

• Is or was recently pregnant
• Has a metal pelvic implant or any electrically active implanted medical device
• Has a urinary tract or vaginal infection
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
• Has a significant heart condition or a history of vasovagal reaction or low blood pressure

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

Treatment

Experimental group

Description:

Active therapy

Treatment:

Device: Treament

Sham Control

Sham Comparator group

Description:

Sham Control

Treatment:

Device: Sham Control