Topics

Use of Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) in Maintaining OAB Symptoms Improvement.

2015-03-12 02:23:23 | BioPortfolio

Summary

This study will help to determine the effectiveness of a self-supervised, home-based Transcutaneous Posterior Tibial Nerve Stimulation treatment protocol in maintaining Overactive Bladder (OAB) symptoms improvement in women responders to Posterior Tibial Nerve Stimulation (PTNS)

Description

Conservative management of OAB includes (NICE, 2006): behavioural therapy (bladder training techniques, prompted voiding, timed voiding…); physical therapy (PFM exercises, Biofeedback, Neuro Muscular Electrical Stimulation…); lifestyle interventions (weight loss, smoking cessation…) and fluid advice (fluid balance, reduction of caffeine intake…). Antimuscarinic agents are recommended if non-pharmacological treatment proves ineffective (NICE, 2006). However, results of behavioural and physical therapy have been shown to fall off by three months after treatment (Burgio et al, 1998). Furthermore, less than one third of patients are compliant with anticholinergic medication after 6 months, mostly due to intolerable side effects, but also to lack of efficacy (Hampel, 2007; Kelleher et al, 1997).

Patients refractory to conservative regimens are candidates in our Physiotherapy Department for peripheral Neuromodulation therapy in the form of Percutaneus Tibial Nerve Stimulation (PTNS). Although its mechanism of action is still poorly understood, its efficacy has been reported to be comparable to that of the antimuscarinic agents, with an objective success rate of 60% (Burton, Sajja & Latthe, 2012), but with a better side effect profile.

TPTNS is a non-invasive technique, easily manageable by patients, which lacks some adverse side effects reported with the use of PTNS, such as bleeding and/or pain at the site of needle insertion. As the technique is self-administered, the associated costs might be substantially lower when compared to PTNS, which involves repeated Hospital appointments for maintenance therapy.

This study will help to determine the effectiveness of a self-supervised, home-based Transcutaneous Posterior Tibial Nerve Stimulation treatment protocol in maintaining Overactive Bladder (OAB) symptoms improvement in women responders to Posterior Tibial Nerve Stimulation (PTNS)

Participants will be assigned to one of the two treatments arms using a computer generated random number table, with assignments drawn from sealed, opaque, serially numbered envelopes.

Participants will be recruited from the Physiotherapy Department at the Liverpool Women's Hospital. Our primary outcome variable will be changes in 24-hour voiding frequency, number of episodes of urgency, as well as number of episodes of urge urinary incontinence. These variables can be reliably measured in self-completed 3-day bladder diaries (Gormley et al, 2012).

As OAB is a symptom-based diagnosis, the quality of life (QoL) impact of the symptoms is a crucial aspect of the condition. We will therefore use as secondary end point the score in the OAB-q questionnaire, a patient-reported outcome measure (PROM) of symptom severity as well as Health Related Quality of Life (HRQOL). The OAB-q has shown good content and construct validity, as well as high internal consistency and good test-retest reliability (Coyne et al, 2006).

Bladder diaries and the OAB-q questionnaire are routinely used in our Department for all patients starting on PTNS (T1). Collection of data will be carried out again at the end of the 12-week course of PTNS. Data obtained at this point (T2) will determine those subjects who are objective responders and who will be invited to enter the trial and be randomized into one of the two treatment arms. During the study period, further assessments will be carried out by the main investigator, who will be blinded to the treatment group allocation, at 6 weeks (T3), 3 months (T4) and 6 months (T5).

PTNS will be performed bilaterally, inserting a 40 mm x 0.25 mm acupuncture needle (Classic Plus Sterile Needle, HMD Europe), three finger breaths cephalad to medial malleolus and posterior to the medial border of the tibia (SP6 acupuncture point). A self-adhesive electrode will be placed on the medial aspect of the calcaneus. The needle and the electrode will be attached to a low voltage electrostimulator (AS SUPER 4 digital, Pierenkemper GmbH, Germany), set up with a pulse duration of 200 μsecs and a frequency of 20 Hz. The amplitude (0-20 mA, adjustable in steps of 0.1 mA) will be increased until flexion of the first toe or fanning of all toes is seen, or tingling sensation in the sole of the foot is reported, always at a tolerable level. Elevation of the Intensity will be allowed whenever the patient describes fading of the above sensation due to accommodation.

TPTNS will be also applied bilaterally, using two surface self-adhesive electrodes in each leg, one placed at SP6 and the other placed on the ankle skin behind the medial malleolus. Electrical stimulation will be applied through a TENS unit (NeuroTrac PelviTone, Verity Medical Ltd, Hampshire, UK) using the same parameters as in the PTNS group.

An experienced Women's Health physiotherapist will conduct the PTNS sessions in the control group and will instruct subjects in the TPTNS group in the stimulation technique. Participants will be provided with a telephone number to contact the research team in case they have any queries or any difficulty with the use of the TENS unit.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Overactive Bladder

Intervention

Transcutaneous Stimulation, Percutaneus Stimulation

Location

Liverpool Women's Hospital
Liverpool
United Kingdom
L8 7SS

Status

Recruiting

Source

Liverpool Women's NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-12T02:23:23-0400

Clinical Trials [4756 Associated Clinical Trials listed on BioPortfolio]

A Trial of Transcutaneous Nerve Stimulation for OAB

Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch...

Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women. ...

Transcutaneous Tibial Nerve Stimulation of Patients With Overactive Bladder (OAB) Syndrome

Tibial nerve stimulation (TNS) has been recognised as a safe and effective treatment for the management of overactive bladder (OAB) symptoms. The aim of this study was to evaluate safety, ...

Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.

A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of t...

PubMed Articles [3274 Associated PubMed Articles listed on BioPortfolio]

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients.

Do Failure of Posterior Tibial Nerve Stimulation Precludes to Use Sacral Neuromodulation in Patient With Overactive Bladder?

To evaluate the outcomes of sacral neuromodulation (SNM) after failure of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with overactive bladder (OAB).

Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder in Women and Men at a Safety-Net Hospital.

To investigate efficacy and compliance related to percutaneous tibial nerve stimulation in patients treated for overactive bladder at a large, urban safety-net hospital.

A comparative study of transcutaneous interferential electrical stimulation and transcutaneous electrical nerve stimulation on children with primary nocturnal enuresis: a randomized clinical trial.

Nocturnal enuresis is an infrequent uncontrolled voiding during sleep in a child aged 5 years or more without any congenital or acquired disorders of the central nervous system.

Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain.

Chronic neck pain is a highly prevalent condition, affecting 10% to 24% of the general population. Transcutaneous electrical nerve stimulation (TENS) is the noninvasive, transcutaneous use of electric...

Medical and Biotech [MESH] Definitions

Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.

Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.

The use of specifically placed small electrodes to deliver electrical impulses across the SKIN to relieve PAIN. It is used less frequently to produce ANESTHESIA.

Stimulation at an intensity below that where a differentiated response can be elicited.

The electrical response evoked in a muscle or motor nerve by electrical or magnetic stimulation. Common methods of stimulation are by transcranial electrical and TRANSCRANIAL MAGNETIC STIMULATION. It is often used for monitoring during neurosurgery.

More From BioPortfolio on "Use of Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) in Maintaining OAB Symptoms Improvement."

Quick Search

Relevant Topics

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial