A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder

EMKinetics

Status

Completed

Conditions

Overactive Bladder

Treatments

Device: EMKinetics non-invasive Magnetic neurostimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01214265

EMK0708C

Details and patient eligibility

About

To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.

Enrollment

8 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women >18 years of age
A score of > 4 on the OAB-q short form for urgency (question 1)
Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary
Self-reported bladder symptoms present > 3 months
Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics.
Off all anti-muscarinics for at least 2 weeks prior to enrollment
Capable of giving informed consent
Ambulatory and able to use a toilet independently, without difficulty
Capable and willing to follow all study-related procedures

Exclusion criteria

The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.)
The patient has an active urinary tract infection.
Neurogenic bladder
Botox use in bladder or pelvic floor muscles in the past year
Pacemakers or implantable defibrillators
Primary complaint of stress urinary incontinence
Current vaginal infection
Current use of InterStim
Current use of Bion
Current use of TENS in the pelvic region, back or leg
Previously been treated with PTNS
Use of investigational drug/device therapy within the past 4 weeks
Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination
The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee (or permanent metallic tattoo <30cm from left ankle).
The patient has chronic constipation (less than two (2) bowel movements per week)
The patient has history of gastric or urinary retention
The patient has uncontrolled diabetes
Subjects with nerve damage, injury or surgery that would impact either tibial nerve or pelvic floor function
The patient is unable or unwilling to sign informed consent
The patient is currently on pharmacologic treatment that could affect bladder function
Known Cystocele >/= to Grade 3 that has not been reduced by treatment (surgery or pessary)