The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.
Overactive bladder syndrome (OAB) is a set of symptoms characterized by urge, with or without urge incontinence, usually with frequency and nocturia in the absence of urinary infection or other pathologies. OAB affect considerably the quality of life of the subject who suffer. The first line of treatment is a conservative management as behavioral interventions, followed by pharmacological management as antimuscarinic or antimuscarinic drugs. Percutaneous tibial nerve stimulation (PTNS) is present as another alternative of treatment. Previous studies have shown the positive effects of PTNS in a reduction on OAB symptoms. The PTNS was described by Stoller in 1999. It's a electrical stimulation of the tibial nerve, inserting a 34 gauge needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia, to stimulation of the sacral segments S2 and S3, where the spinal centre of bladder is located. The parameters used are 20Hz and 200 µs, 12 sessions, two weekly, 30 min treatment. The PTNS is a minimal invasive technique, but can be utilized surface electrodes instead of needle to minimize the discomfort of prick. The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
Laura Calzado Sanz
Alcalá de Henares, Madrid, Spain
RECRUITINGUrinary frequency
Urinary episodes per day. According to international consensus, it is considered pathological when: There are more than 8 episodes of urination per day
Time frame: two years
Nightime voids
Urinary episodes per night. According to international consensus, it is considered pathological when: There is more than 1 episode per night.
Time frame: two years
Urge episodes
Urinary urge episodes per day. The degree of urgency is measured through the PPIUS scale (outcome no. 4). A grade 3-4 on the PPIUS scale is considered pathological.
Time frame: two years
Degree of urge to void
Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale). Scale from 0 to 4, where: 0 = No urgency; 1. = Slight urgency; 2. = Moderate urgency; 3. = severe urgency; 4. = urge incontinence.
Time frame: two years
Voided volume
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
Time frame: two years
Overactive Bladder questionnaire Short- Form (OABq-SF)
This is a questionnaire that evaluates both the symptoms and the quality of life of the patient: * Symptom involvement (6 questions): Score of 6-36 * Quality of life (13 questions): Score of 13-78 * 0-100 metric scale. The higher the score, the more severity.
Time frame: Two years
International Consultation on Incontinence Questionnaire (ICIQ-SF)
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This is a self-administered questionnaire that identifies people with urine incontinence (UI) and also assess the impact on quality of life. ICIQ-SF Score: Adding the scores to questions 1+2+3, a score above zero is considered a diagnosis of UI.
Time frame: Two years
Benefits, satisfaction and willingness to continue to treatment (BSW)
The BSD12 questionnaire is a 3 item likert-type questionnaire (benefit, satisfaction and willingness) with an overall score of 0 to 10. Higher scores indicates a better perception of benefit and satisfaction with the treatment, and a greater willingness to continue with it.
Time frame: Two years