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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2023-09-01

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.

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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.

Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective interventional study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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A: Transcutaneous tibial nerve stimulation

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.

Group Type EXPERIMENTAL

Transcutaneous tibial nerve stimulation

Intervention Type DEVICE

Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

B: Percutaneous tibial nerve stimulation

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.

Group Type ACTIVE_COMPARATOR

Percutaneous tibial nerve stimulation

Intervention Type DEVICE

Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

Interventions

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Transcutaneous tibial nerve stimulation

Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

Intervention Type DEVICE

Percutaneous tibial nerve stimulation

Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes