Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Overactive Bladder.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Overactive Bladder. Randomized Clinical Trial.

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Device: Transcutaneous tibial nerve stimulation
* Device: Percutaneous tibial nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects diagnosis of overactive bladder Subjects refractory to treatments antimuscarinic or beta 3-agonist Subjects who do not take restricted medication Subjects who can cognitively complete the voiding diary and questionnaires Subject with symptoms 3 months ago Men must be discarded obstruction by benign prostatic hyperplasia Exclusion Criteria: Subjects with stress incontinence Subjects with urinary tract infection Subjects with neurological disease Subjects with pacemakers fitted Pregnancy Subjects who have disorder sensitive A history of pelvic tumors Subject who is not able to understand the physiotherapist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective interventional study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Transcutaneous tibial nerve stimulation<br>The transcutaneous electrostimulation of the posterior tibial nerve (ETNTP) will be applied to group A: place two surface electrodes, one 32 mm in diameter, 5 cm cephalad of the internal malleolus and 1 cm medial posterior of the tibia; and another 50x50 mm electrode in the calcaneous. The flexion of the first toe will indicate the correct placement of the electrodes. Stimulation is performed according to the Stoller method with a stimulator programmed at 20Hz and 200 µs, with a continuous current, 12 sessions, 2 weekly are completed. The intensity of the current will be tolerance by the subject. | Device: Transcutaneous tibial nerve stimulation<br>* Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.<br>|
| Active Comparator: B: Percutaneous tibial nerve stimulation<br>The percutaneous electrostimulation of the posterior tibial nerve (EPNTP) will be applied to group B: inserting a 0.25x30mm surgical steel needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia , and a surface electrode of 50x50 mm in the calcaneous. The flexion of the first finger will indicate its correct placement. The stimulation parameters will also follow the Stoller method. | Device: Percutaneous tibial nerve stimulation<br>* Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary frequency | Urinary episodes per day. According to international consensus, it is considered pathological when: There are more than 8 episodes of urination per day | 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. | 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. | 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; = Slight urgency; = Moderate urgency; = severe urgency; = urge incontinence. | two years | 
| Voided volume | Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two years | 
| International Consultation on Incontinence Questionnaire (ICIQ-SF) | 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. | 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. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urgency, incontinence, nocturia, frequency