Overactive BladderNCT02657057
Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB
A study testing PTNS and TENS SNS in people with Overactive Bladder and Urge Incontinence, run by Instituto Médico Tecnológico SL at 1 site in Spain.
Trial summary
The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as 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
- Conditions the study is for
- Overactive Bladder, Urge Incontinence, Overactive Detrusor
- What is being tested?
- PTNS and TENS SNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Mar 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male
- Age >18 years
- 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)
- Urodynamic data of overactive detrusor
- 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 to complete study questionnaires and informed consent study
Who cannot join
- Presence of bladder obstruction (prostate or prolapse)
- Neurogenic bladder overactivity
- Previous pelvic organ prolapse surgery
- Unwilling and mentally incompetent to participate in study
- Pregnancy or planning to become pregnant during the study
- Presence of urinary fistula
Show all 20Show fewer
- Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
- Bladder stones
- Bladder cancer or suspected bladder cancer
- Hematuria
- 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 and diabetes with peripheral nerve involvement
- Anticoagulants treatment
- 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
- Urinary retention or gastric retention
- Painful Bladder Syndrome/Interstitial Cystitis
- Previous PTNS treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.
Read the detailed description
Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy.
The investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial.
Secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies.
- Conditions
- Overactive Bladder, Urge Incontinence, Overactive Detrusor
- Being tested
- PTNS, TENS SNS
- Keywords
- neuromodulation, electrical estimulation, percutaneous, transcutaneous, OAB
- 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.
PTNSDevice
Also called Percutaneous Tibial Nerve Stimulation (URO stim2)
The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). 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.
TENS SNSDevice
Also called Transcutaneous Tibial Nerve Stimulation (URO stim2)
Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). 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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Experimental | TENS SNS therapy is performed as follows; patient is asked to sit with legs slightly bent and an adhesive electrode is attached transcutaneously 5cm cephalic to either the right or left medial malleolus (subject choice). A surface electrode is placed on the medial surface of the ipsilateral calcaneum and both electrodes are connected to a low voltage electronic stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy. Receives: Device: TENS SNS |
| Percutaneous Tibial Nerve Stimulation | Active comparator | PTNS therapy is performed as follows; patient is asked to sit with legs slightly bent. 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 surface of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage electrical stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and the subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy. Receives: Device: PTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks
A reduction in urinary frequency was regarded clinically significant when a normal voiding pattern of less than 8 voids per 24 hours could be obtained
Measured: 12 weeks
Secondary outcomes (6)
Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks
A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant
Measured: 6 and 12 weeks
Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks
A reduction in number of urgency episodes at 6 weeks and 12 weeks
Measured: 6 and 12 weeks
Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks
A reduction of at least 25% was regarded significant
Measured: 6 and 12 weeks
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
An improvement of at least 10 points was regarded significant
Measured: 6 and 12 weeks
Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks
An improvement of at least 10 points was regarded significant
Measured: 6 and 12 weeks
Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks
A score of 1 or 2 was regarded significant
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionMar 2017
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Médico Tecnológico SL
- Sponsor type
- University, hospital or other
- Collaborators
- University Ramon Llull
- Responsible party
- Principal investigator, Inés Ramírez García, Instituto Médico Tecnológico SL
- Investigators
- Inés Ramírez, MSc, Principal investigator, Instituto Médico Tecnológico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657057
- Sponsor's protocol ID
- IMT46681770
- Status last verified
- Aug 2017
- First submitted
- 20 Dec 2015
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02657057
- Acronym / sponsor ID
- IMT46681770
- Conditions
- Overactive Bladder, Urge Incontinence, Overactive Detrusor
- Keywords
- neuromodulation, electrical estimulation, percutaneous, transcutaneous, OAB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Instituto Médico Tecnológico SLUniversity, hospital or other
- Collaborators
- University Ramon Llull
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Jan 2016 (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 if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.
Detailed description
Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy.
The investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial.
Secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Experimental | Device: TENS SNSTENS SNS therapy is performed as follows; patient is asked to sit with legs slightly bent and an adhesive electrode is attached transcutaneously 5cm cephalic to either the right or left medial malleolus (subject choice). A surface electrode is placed on the medial surface of the ipsilateral calcaneum and both electrodes are connected to a low voltage electronic stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy. |
| Percutaneous Tibial Nerve Stimulation | Active comparator | Device: PTNSPTNS therapy is performed as follows; patient is asked to sit with legs slightly bent. 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 surface of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage electrical stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and the subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female and male
- Age >18 years
- 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)
- Urodynamic data of overactive detrusor
- Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
Key exclusion criteria (20 listed)
- Presence of bladder obstruction (prostate or prolapse)
- Neurogenic bladder overactivity
- Previous pelvic organ prolapse surgery
- Unwilling and mentally incompetent to participate in study
- Pregnancy or planning to become pregnant during the study
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 |
|---|---|---|
| PTNSAlso: Percutaneous Tibial Nerve Stimulation (URO stim2)The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). 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. | Device | Percutaneous Tibial Nerve Stimulation |
| TENS SNSAlso: Transcutaneous Tibial Nerve Stimulation (URO stim2)Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). 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. | Device | Transcutaneous Tibial Nerve Stimulation |
Primary outcome
Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks
Time frame: 12 weeks
A reduction in urinary frequency was regarded clinically significant when a normal voiding pattern of less than 8 voids per 24 hours could be obtained
6 secondary outcomes
Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks
Time frame: 6 and 12 weeks
Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks
Time frame: 6 and 12 weeks
Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks
Time frame: 6 and 12 weeks
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
Time frame: 6 and 12 weeks
Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks
Time frame: 6 and 12 weeks
Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks
Time frame: 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
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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.
Inés Ramírez, MSc principal investigator
Instituto Médico Tecnológico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS and TENS SNS in people with Overactive Bladder and Urge Incontinence, run by Instituto Médico Tecnológico SL at 1 site in Spain.
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 7 inclusion and 20 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: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks (time frame: 12 weeks). 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 21 Aug 2017.