A Pilot Clinical Study to Evaluate the Initial Feasibility of Neuromodulation Therapy in Treating Patients With Overactive Bladder Via Magnetic Stimulation of the Posterior Tibial Nerve

EMKinetics, Inc1 site in 1 country8 target enrollmentOctober 2009

ConditionsOveractive Bladder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: EMKinetics, Inc
Enrollment: 8
Locations: 1
Primary Endpoint: Global Response Assessment
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

June 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

EMKinetics, Inc

Eligibility Criteria

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

Outcomes

Primary Outcomes

Global Response Assessment

Time Frame: After 12 weeks of therapy

Improved score on the Global Response Assessment (GRA) scale after 12 weeks of therapy. A score of 2 (moderately improved) or 3 (markedly improved) constitutes a responder on the 7 point scale