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Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

Primary Purpose

Overactive Bladder, Urge Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTNS (Percutaneous Tibial Nerve Stimulation
TENS (Transcutaneous Electrical Nerve Stimulation)
Sponsored by
Walter Reed National Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, TENS, PTNS, Electrical Nerve Stimulation, Urge Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Walter Reed National Military Medical Center
  • Fort Belvoir Community Hospital
  • Portsmouth Naval Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PTNS Arm

TENS Arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
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
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
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
Changes in urodynamic studies (i.e. bladder capacity, uroflow rate, post-void residual).

Full Information

First Posted
August 13, 2013
Last Updated
April 27, 2016
Sponsor
Walter Reed National Military Medical Center
Collaborators
International Urogynecological Association (Grant), Section on Women's Health (Grant)
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1. Study Identification

Unique Protocol Identification Number
NCT01940367
Brief Title
Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
Official Title
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
International Urogynecological Association (Grant), Section on Women's Health (Grant)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Urinary Incontinence
Keywords
Overactive Bladder, TENS, PTNS, Electrical Nerve Stimulation, Urge Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTNS Arm
Arm Type
Active Comparator
Arm Description
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).
Arm Title
TENS Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PTNS (Percutaneous Tibial Nerve Stimulation
Other Intervention Name(s)
Urgent ® PC Neuromodulation System
Intervention Description
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
Intervention Name(s)
TENS (Transcutaneous Electrical Nerve Stimulation)
Other Intervention Name(s)
EMPI TENS Select
Intervention Description
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
Primary Outcome Measure Information:
Title
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Description
Participant compliance defined as 75% adherence to the recommended use for each device.
Time Frame
2 years
Title
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Description
Changes in the OAB-q (Overactive Bladder Questionnaire), the PFDI (Pelvic Floor Distress Inventory), and the FSFI (Female Sexual Function Index)
Time Frame
2 Years
Title
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Description
Changes in urodynamic studies (i.e. bladder capacity, uroflow rate, post-void residual).
Time Frame
2 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E McVearry, DPT, WCS
Organizational Affiliation
Walter Reed National Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Portsmouth Naval Hospital
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

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