Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Walter Reed National Military Medical Center
Sponsor:
Collaborators:
International Urogynecological Association (Grant)
Section on Women's Health (Grant)
Information provided by (Responsible Party):
Shannon Lamb, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01940367
First received: August 13, 2013
Last updated: September 7, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Overactive Bladder
Urge Urinary Incontinence
Device: PTNS (Percutaneous Tibial Nerve Stimulation
Device: TENS (Transcutaneous Electrical Nerve Stimulation)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Participant compliance defined as 75% adherence to the recommended use for each device.

  • Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Changes in the OAB-q (Overactive Bladder Questionnaire), the PFDI (Pelvic Floor Distress Inventory), and the FSFI (Female Sexual Function Index)

  • Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Changes in urodynamic studies (i.e. bladder capacity, uroflow rate, post-void residual).


Estimated Enrollment: 114
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: EMPI TENS Select

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940367

Locations
United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: Shannon V Lamb, MD    571-212-9206    shanpas@hotmail.com   
Contact: Mary E McVearry, DPT, WCS    301-400-2656    mary.e.mcvearry.ctr@health.mil   
Sub-Investigator: Shannon V Lamb, MD         
Principal Investigator: Mary E McVearry, DPT, WCS         
Sponsors and Collaborators
Walter Reed National Military Medical Center
International Urogynecological Association (Grant)
Section on Women's Health (Grant)
Investigators
Principal Investigator: Mary E McVearry, DPT, WCS Walter Reed National Military Medical Center
  More Information

No publications provided

Responsible Party: Shannon Lamb, Physician, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01940367     History of Changes
Other Study ID Numbers: 385408-2
Study First Received: August 13, 2013
Last Updated: September 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Walter Reed National Military Medical Center:
Overactive Bladder
TENS
PTNS
Electrical Nerve Stimulation
Urge Urinary Incontinence

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

ClinicalTrials.gov processed this record on July 23, 2014