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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: EMKinetics non-invasive Magnetic neurostimulator

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • The Incontinence and Pelvic Support Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Response Assessment	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	After 12 weeks of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Frequency	Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks	After 12 weeks of therapy
Urinary Incontinence	Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks	After 12 weeks of therapy
Overactive Bladder Symptoms (OAB-q SF)	Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks	After 12 weeks of therapy

Collaborators and Investigators

• Sponsor: EMKinetics, Inc

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (Estimate): October 5, 2010

Study Record Updates

• Last Update Posted (Estimate): October 26, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: EMK0708C