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

Fisiocore LC,SL

Status: Enrolling

Conditions: Overactive Bladder Syndrome

Treatments: Device: Transcutaneous tibial nerve stimulation; Device: Percutaneous tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04483817

EC 06/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

A: Transcutaneous tibial nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous tibial nerve stimulation

B: Percutaneous tibial nerve stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Percutaneous tibial nerve stimulation