Overactive BladderNCT01940367
Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
A study testing PTNS (Percutaneous Tibial Nerve Stimulation and TENS (Transcutaneous Electrical Nerve Stimulation) in people with Overactive Bladder and Urge Urinary Incontinence, run by Walter Reed National Military Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urge Urinary Incontinence
- What is being tested?
- PTNS (Percutaneous Tibial Nerve Stimulation and TENS (Transcutaneous Electrical Nerve Stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
Portsmouth Naval Hospital
Portsmouth, Virginia, 23708
About this study
Official title: 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.
Read the 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
- Being tested
- PTNS (Percutaneous Tibial Nerve Stimulation, TENS (Transcutaneous Electrical Nerve Stimulation)
- Keywords
- Overactive Bladder, TENS, PTNS, Electrical Nerve Stimulation, Urge Urinary Incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNS (Percutaneous Tibial Nerve StimulationDevice
Also called Urgent ® PC Neuromodulation System
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 (Transcutaneous Electrical Nerve Stimulation)Device
Also called EMPI TENS Select
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
| Study group | Role | What they receive |
|---|---|---|
| PTNS Arm | Active comparator | 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). Receives: Device: PTNS (Percutaneous Tibial Nerve Stimulation |
| TENS Arm | Active comparator | 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. Receives: Device: TENS (Transcutaneous Electrical Nerve Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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)
Measured: 2 Years
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).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- International Urogynecological Association, Section on Women's Health (Grant)
- Responsible party
- Principal investigator, Shannon Lamb, Walter Reed National Military Medical Center
- Investigators
- Mary E McVearry, DPT, WCS, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940367
- Sponsor's protocol ID
- 385408-2
- Status last verified
- Apr 2016
- First submitted
- 13 Aug 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01940367
- Acronym / sponsor ID
- 385408-2
- Conditions
- Overactive Bladder, Urge Urinary Incontinence
- Keywords
- Overactive Bladder, TENS, PTNS, Electrical Nerve Stimulation, Urge Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- International Urogynecological Association, Section on Women's Health (Grant)
- Study start
- Oct 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTNS Arm | Active comparator | Device: PTNS (Percutaneous Tibial Nerve StimulationSubjects 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). |
| TENS Arm | Active comparator | Device: TENS (Transcutaneous Electrical Nerve Stimulation)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTNS (Percutaneous Tibial Nerve StimulationAlso: Urgent ® PC Neuromodulation SystemPTNS 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. | Device | PTNS Arm |
| TENS (Transcutaneous Electrical Nerve Stimulation)Also: EMPI TENS SelectTENS 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 | Device | TENS Arm |
Primary outcome
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.
3 secondary outcomes
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time frame: 2 years
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time frame: 2 Years
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Related trials for Overactive Bladder
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E McVearry, DPT, WCS principal investigator
Walter Reed National Military Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS (Percutaneous Tibial Nerve Stimulation and TENS (Transcutaneous Electrical Nerve Stimulation) in people with Overactive Bladder and Urge Urinary Incontinence, run by Walter Reed National Military Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.