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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214265
• Other study ID #: EMK0708C
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: October 22, 2010
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: EMKinetics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
United States	The Incontinence and Pelvic Support Institute	Mission Viejo	California

Sponsors (1)

Lead Sponsor	Collaborator
EMKinetics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Urinary Frequency	Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks	After 12 weeks of therapy
Secondary	Urinary Incontinence	Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks	After 12 weeks of therapy
Secondary	Overactive Bladder Symptoms (OAB-q SF)	Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks	After 12 weeks of therapy