Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

NCT ID: NCT01940367

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

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.

Conditions

Overactive Bladder; Urge Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

PTNS (Percutaneous Tibial Nerve Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

TENS (Transcutaneous Electrical Nerve Stimulation)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Urgent ® PC Neuromodulation System; EMPI TENS Select

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

International Urogynecological Association

OTHER

Sponsor Role: collaborator

Section on Women's Health (Grant)

UNKNOWN

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Shannon Lamb

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary E McVearry, DPT, WCS

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Portsmouth Naval Hospital

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

385408-2

Identifier Type: -

Identifier Source: org_study_id