Overactive Bladder Syndrome
Conditions
Keywords
urgency, incontinence, nocturia, frequency
Brief summary
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
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.
Interventions
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.
Sponsors
Fisiocore LC,SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
prospective interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voided volume | two years | Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological. |
| Nightime voids | two years | Urinary episodes per night. According to international consensus, it is considered pathological when: There is more than 1 episode per night. |
| Urge episodes | two years | 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. |
| Degree of urge to void | two years | 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. |
| Urinary frequency | two years | Urinary episodes per day. According to international consensus, it is considered pathological when: There are more than 8 episodes of urination per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Questionnaire (ICIQ-SF) | Two years | 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. |
| Benefits, satisfaction and willingness to continue to treatment (BSW) | Two years | 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. |
| Overactive Bladder questionnaire Short- Form (OABq-SF) | Two years | 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. |
Countries
Spain
Contacts
Primary ContactLaura Calzado Sanz, Physiotherap
Backup ContactMaría Torres Lacomba, Physiotherap
Outcome results
None listed