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Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

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ClinicalTrials.gov Identifier: NCT02657057
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
University Ramon Llull
Information provided by (Responsible Party):
Inés Ramírez García, Instituto Médico Tecnológico SL

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urge Incontinence Overactive Detrusor Device: PTNS Device: TENS SNS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
Study Start Date : November 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcutaneous Tibial Nerve Stimulation
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.
Device: TENS SNS
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.
Other Name: Transcutaneous Tibial Nerve Stimulation (URO stim2)

Active Comparator: Percutaneous Tibial Nerve Stimulation
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.
Device: PTNS
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.
Other Name: Percutaneous Tibial Nerve Stimulation (URO stim2)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks [ Time Frame: 6 and 12 weeks ]
    A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant

  2. 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 ]
    A reduction in number of urgency episodes at 6 weeks and 12 weeks

  3. Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks [ Time Frame: 6 and 12 weeks ]
    A reduction of at least 25% was regarded significant

  4. Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL) [ Time Frame: 6 and 12 weeks ]
    An improvement of at least 10 points was regarded significant

  5. Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks [ Time Frame: 6 and 12 weeks ]
    An improvement of at least 10 points was regarded significant

  6. Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks [ Time Frame: 6 and 12 weeks ]
    A score of 1 or 2 was regarded significant


Other Outcome Measures:
  1. Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints [ Time Frame: 12 weeks ]
    A number of at least 50% was regarded significant

  2. Number of complaints OR adverse effects registered during treatments [ Time Frame: From Baseline to week 12 ]
    complaints and side effects were registered



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657057


Locations
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Spain
Inés Ramírez
Barcelona, Spain, 08024
Sponsors and Collaborators
Instituto Médico Tecnológico SL
University Ramon Llull
Investigators
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Principal Investigator: Inés Ramírez, MSc Instituto Médico Tecnológico

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Responsible Party: Inés Ramírez García, Physiotherapist, MSc, Instituto Médico Tecnológico SL
ClinicalTrials.gov Identifier: NCT02657057     History of Changes
Other Study ID Numbers: IMT46681770
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Inés Ramírez García, Instituto Médico Tecnológico SL:
neuromodulation
electrical estimulation
percutaneous
transcutaneous
OAB

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