Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Overactive Bladder. Randomized Clinical Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder Syndrome
- Sponsor
- Fisiocore LC,SL
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Urinary frequency
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Urinary frequency
Time Frame: 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
Urge episodes
Time Frame: 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.
Voided volume
Time Frame: two years
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
Degree of urge to void
Time Frame: 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.
Nightime voids
Time Frame: two years
Urinary episodes per night. According to international consensus, it is considered pathological when: There is more than 1 episode per night.
Secondary Outcomes
- Overactive Bladder questionnaire Short- Form (OABq-SF)(Two years)
- International Consultation on Incontinence Questionnaire (ICIQ-SF)(Two years)
- Benefits, satisfaction and willingness to continue to treatment (BSW)(Two years)