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

NCT01214265 | Completed

• 1 other identifier: EMK0708C
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Urinary Frequency

  After 12 weeks of therapy

• Urinary Incontinence

  After 12 weeks of therapy

• Overactive Bladder Symptoms (OAB-q SF)

  After 12 weeks of therapy

Interventions

EMKinetics non-invasive Magnetic neurostimulator DEVICE

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• EMKinetics, Inc: lead

Study Sites (1)

The Incontinence and Pelvic Support Institute

Mission Viejo, California, 92691, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

US (1)