Inés Ramírez
Barcelona, 08024, Spain
NCT Number: NCT02657057
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08024, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Percutaneous 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.
Other names: Transcutaneous Tibial Nerve Stimulation (URO stim2)
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
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
Time frame: 6 and 12 weeks
A reduction in number of urgency episodes at 6 weeks and 12 weeks
Time frame: 6 and 12 weeks
A reduction of at least 25% was regarded significant
Time frame: 6 and 12 weeks
An improvement of at least 10 points was regarded significant
Time frame: 6 and 12 weeks
An improvement of at least 10 points was regarded significant
Time frame: 6 and 12 weeks
A score of 1 or 2 was regarded significant
Time frame: 12 weeks
A number of at least 50% was regarded significant
Time frame: From Baseline to week 12
complaints and side effects were registered
Instituto Médico Tecnológico SL
Other
Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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