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

This study has been completed.
Sponsor:
Information provided by:
EMKinetics, Inc
ClinicalTrials.gov Identifier:
NCT01214265
First received: October 1, 2010
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Overactive Bladder
 Device: EMKinetics non-invasive Magnetic neurostimulator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by EMKinetics, Inc:

Primary Outcome Measures:
  • Global Response Assessment [ Time Frame: After 12 weeks of therapy ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Urinary Frequency [ Time Frame: After 12 weeks of therapy ] [ Designated as safety issue: No ]
    Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks

  • Urinary Incontinence [ Time Frame: After 12 weeks of therapy ] [ Designated as safety issue: No ]
    Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks

  • Overactive Bladder Symptoms (OAB-q SF) [ Time Frame: After 12 weeks of therapy ] [ Designated as safety issue: No ]
    Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks


Enrollment: 8
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EMKinetics non-invasive Magnetic neurostimulator
    Patients will be treated with 12 weekly sessions of magnetic stimulation of the posterior tibial nerve at 20 hz using the EMKinetics non-invasive Magnetic neurostimulator.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214265

Locations
United States, California
The Incontinence and Pelvic Support Institute
Mission Viejo, California, United States, 92691
Sponsors and Collaborators
EMKinetics, Inc
  More Information

No publications provided

Responsible Party: Amit Rajguru, MD, EMKinetics, Inc
ClinicalTrials.gov Identifier: NCT01214265     History of Changes
Other Study ID Numbers: EMK0708C
Study First Received: October 1, 2010
Last Updated: October 22, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013