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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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.
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.
Inés Ramírez
Barcelona, Spain
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
Time frame: 12 weeks
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
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
A reduction in number of urgency episodes at 6 weeks and 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
A reduction of at least 25% was regarded significant
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 6 and 12 weeks