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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Transcutaneous tibial nerve stimulation | Experimental | 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. |
|
| B: Percutaneous tibial nerve stimulation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous tibial nerve stimulation | Device | Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder. |
|
| 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;
| two years |
| Voided volume | Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological. | two years |
| 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:
| Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Calzado Sanz, Physiotherap | Contact | +34 626495479 | lauracalzado@lcfisioterapia.com | |
| María Torres Lacomba, Physiotherap | Contact | +34 678900061 | maria.torres@uah.es |
| Name | Affiliation | Role |
|---|---|---|
| Laura Calzado Sanz, Physiotherap | Fisiocore LC,SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Calzado Sanz | Recruiting | Alcalá de Henares | Madrid | 28806 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26586384 | Background | Wibisono E, Rahardjo HE. Effectiveness of Short Term Percutaneous Tibial Nerve Stimulation for Non-neurogenic Overactive Bladder Syndrome in Adults: A Meta-analysis. Acta Med Indones. 2015 Jul;47(3):188-200. | |
| 20590544 | Result | Yoong W, Ridout AE, Damodaram M, Dadswell R. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int. 2010 Dec;106(11):1673-6. doi: 10.1111/j.1464-410X.2010.09461.x. |
| Label | URL |
|---|---|
| Guidelines of urology´s treatments | View source |
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| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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prospective interventional study
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| Percutaneous tibial nerve stimulation | Device | Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder. |
|
| 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 |
| 21092997 | Result | Civic D, Black E. Re: Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial: K. M. Peters, D. J. Carrico, R. A. Perez-Marrero, A. U. Khan, L. S. Wooldridge, G. L. Davis and S. A. MacDiarmid J Urol 2010; 183: 1438-1443. J Urol. 2011 Jan;185(1):362; author reply 362-4. doi: 10.1016/j.juro.2010.09.030. Epub 2010 Nov 18. No abstract available. |
| 20567947 | Result | Sajadi KP, Goldman HB. Percutaneous tibial nerve stimulation and overactive bladder. Curr Urol Rep. 2010 Sep;11(5):293-5. doi: 10.1007/s11934-010-0126-4. No abstract available. |
| 28731583 | Result | Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The effectiveness of transcutaneous tibial nerve stimulation (TTNS) for adults with overactive bladder syndrome: A systematic review. Neurourol Urodyn. 2018 Feb;37(2):528-541. doi: 10.1002/nau.23351. Epub 2017 Jul 21. |
| 22581511 | Result | Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012 Nov;31(8):1206-16. doi: 10.1002/nau.22251. Epub 2012 May 11. |
| Guidelines of AEU (Asociación Española de Urología) | View source |