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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMKinetics non-invasive Magnetic neurostimulator
Sponsored by
EMKinetics, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • The Incontinence and Pelvic Support Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Urinary Frequency
Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks
Urinary Incontinence
Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks
Overactive Bladder Symptoms (OAB-q SF)
Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks

Full Information

First Posted
October 1, 2010
Last Updated
October 22, 2010
Sponsor
EMKinetics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01214265
Brief Title
A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
EMKinetics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
EMKinetics non-invasive Magnetic neurostimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Response Assessment
Description
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
Time Frame
After 12 weeks of therapy
Secondary Outcome Measure Information:
Title
Urinary Frequency
Description
Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks
Time Frame
After 12 weeks of therapy
Title
Urinary Incontinence
Description
Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks
Time Frame
After 12 weeks of therapy
Title
Overactive Bladder Symptoms (OAB-q SF)
Description
Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks
Time Frame
After 12 weeks of therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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)
Facility Information:
Facility Name
The Incontinence and Pelvic Support Institute
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States

12. IPD Sharing Statement

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

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