Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

April 27, 2016 updated by: Shannon Lamb, Walter Reed National Military Medical Center

Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial

The purpose of this study is to determine whether transcutaneous sacral nerve stimulation (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed conventional therapy. Our primary hypothesis is that TENS therapy is a more effective treatment option due to ease of use and improved subject compliance with this form of therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To compare the long-term efficacy, subject compliance, and subject satisfaction of percutaneous tibial nerve stimulation (PTNS) therapy versus transcutaneous electrical sacral nerve stimulation (TENS) for the treatment of subjects with idiopathic overactive bladder. Previous short-term studies suggest that these therapies have equal efficacy in improving OAB symptoms, but we hypothesize that long-term efficacy and success is actually higher in the TENS group due to ease of use, since subjects can self-administer this therapy. Secondary goals are to evaluate subject quality of life improvement scores, bladder diary scores (change in the frequency of urination), and changes in urodynamic studies while undergoing these therapies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Fort Belvoir Community Hospital
      • Portsmouth, Virginia, United States, 23708
        • Portsmouth Naval Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age >18 years
  • Predominant complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)
  • Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
  • Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
  • Willing and mentally competent to participate in study
  • Willing to complete study questionnaires
  • No contraindications to undergoing PTNS or TENS therapy

Exclusion Criteria:

  • Age < 18 years
  • Presence of urinary fistula
  • Male. (Males will be excluded because of the different etiology of overactive bladder for males which is primarily caused by prostate problems for men versus the primarily idiopathic cause in women).
  • Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
  • Bladder stones
  • Bladder cancer or suspected bladder cancer
  • Hematuria
  • Pregnancy or planning to become pregnant during the study (urine pregnancy test will be administered to those who are premenopausal and who have not had a hysterectomy)
  • Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion
  • Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).
  • Uncontrolled diabetes
  • Diabetes with peripheral nerve involvement
  • On anticoagulants
  • Current use of anticholinergics or use within the last 4 weeks
  • Current use of botox bladder injections or bladder botox injection within the last year
  • Current use of interstim therapy or currently implanted interstim device or leads
  • Bladder outlet obstruction
  • Urinary retention or gastric retention
  • Painful Bladder Syndrome/Interstitial Cystitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PTNS Arm
Subjects randomized to the PTNS arm will undergo PTNS treatment once weekly for 30 minutes for 12 weeks total. If at 12 weeks they are considered to have a positive response to therapy, they will continue maintenance therapy in a tapered fashion: subjects will come in every 2 weeks for the next 8 weeks for 30 minute treatments (4 visits total), then every 3-4 weeks for 30 minute treatments for the remaining 32 weeks of the year (8-10 visits).
Device: PTNS (Percutaneous Tibial Nerve Stimulation
PTNS therapy is performed as follows; the subject sits in a frog leg position in a chair. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial aspect of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage (9 V) electrical stimulator (Urgent PC). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot. The current is then set to the highest level tolerable to the subject (0-10 mA) and the subject undergoes therapy for 30 minutes.
Other Names:
  • Urgent ® PC Neuromodulation System
Active Comparator: TENS Arm
Subjects randomized to the TENS arm of the study will begin therapy after their baseline evaluation is complete. They will be issued a home TENS device (EMPI TENS Select) and will administer self-treatment daily for 2 hours per day (1 hour in the morning and 1 hour in the evening) for a total of 12 weeks. If they are considered to have a positive response with TENS treatment, subjects will continue by weaning use over a three-month time period. They will begin with 3 x per week for 1 month, then 2 x per week for 1 month, then 1 x per week for 1 month, all at 2 hours per day.
Device: TENS (Transcutaneous Electrical Nerve Stimulation)

TENS therapy will be administered as follows:

  • Surface electrodes, 2" x 2" in diameter, will be placed over sacral foramen S2-4, bilaterally, using 2 channels (4 electrodes total) - Approximate locations are over posterior superior iliac spine and inferior lateral angle of sacrum. Sticker electrodes for the duration of the study will be issued to subjects. They are adhesive and can be re-used for up to 3-4 weeks with proper skin care and electrode care.

  • The electrodes will be connected to the TENS (Transcutaneous Electrical Nerve Stimulation) device and the following settings will be pre-set:

    • Mode: Burst
    • Cycle: 10 seconds
    • Frequency: 10 Hz
    • Pulse Width: 250 µs
    • Intensity: to subject comfort level
Other Names:
  • EMPI TENS Select

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time Frame: 2 years
The primary response variable is 'success' at 1 year, defined as a 50% or more reduction in the total number of incontinence episodes, or a 25% or more reduction in number of daily or nightly voids AND that the patient continues to use the therapy at one year. Therefore primary response is: 50% reduction in incontinence, OR 25% reduction in nightly voids AND continued use of therapy at one year.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time Frame: 2 years
Participant compliance defined as 75% adherence to the recommended use for each device.
2 years
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time Frame: 2 Years
Changes in the OAB-q (Overactive Bladder Questionnaire), the PFDI (Pelvic Floor Distress Inventory), and the FSFI (Female Sexual Function Index)
2 Years
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time Frame: 2 Years
Changes in urodynamic studies (i.e. bladder capacity, uroflow rate, post-void residual).
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Walter Reed National Military Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Urogynecological Association (Grant)
Section on Women's Health (Grant)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary E McVearry, DPT, WCS, Walter Reed National Military Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 385408-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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