Monday, 22 September 2014

Bladder trial

Gaspard L, Tombal B, Opsomer RJ, Castille Y, Van Pesch V, Detrembleur C.[Physiotherapy and neurogenic lower urinary tract dysfunction in multiple sclerosis patients: A randomized controlled trial]. Prog Urol. 2014; 24(:697-707.

AIM: This randomized controlled trial compare the efficacy of pelvic floor muscle training vs. transcutaneous posterior tibial nerve stimulation.
PATIENTS AND METHODS:Inclusion criteria were EDSS score<7 and presence of lower urinary tract symptoms. The primary outcome was quality of life questionnaire. Secondary outcomes included overactive bladder questionnaire and frequency of urgency episodes Sample size was calculated after 18 patients were included. Data analysis was blinded. Each patient received 9 sessions of 30minutes weekly. Patients were randomized in pelvic floor muscles exercises with biofeedback group (muscle endurance and relaxation) or transcutaneous posterior tibial nerve stimulation group (rectangular alternative biphasic current with low frequency).
RESULTS:A total of 31 patients were included. No difference appeared between groups for quality of life, overactive bladder and frequency of urgency episodes (respectively P=0.197, P=0.532 et P=0.788). These parameters were significantly improved in pelvic floor muscle training group (n=16) (respectively P=0.004, P=0.002 et P=0.006) and in transcutaneous posterior tibial nerve stimulation group (n=15) (respectively P=0.001, P=0.001 et P=0.031).
CONCLUSIONS:Pelvic floor muscle training and transcutaneous posterior tibial nerve stimulation improved in the same way symptoms related to urgency in MS patients with mild disability.

Percutaneous tibial nerve stimulation (PTNS), also referred to as posterior tibial nerve stimulation, is used to treat overactive bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.

PTNS can be used as a primary therapy. However, treatment for an overactive bladder is initially conservative followed by drugs. As pelvic floor training improves symptoms this should be attempted as a first-step, particularly in women who have had children.

During the PTNS procedure, the patient sits comfortably with the treatment leg elevated. A fine needle electrode is inserted into the lower, inner aspect of the leg. As the goal is to send stimulation through the tibial nerve, it is important to have the needle electrode near (but not on) the tibial nerve. A surface electrode (grounding pad) is placed on the same leg. The needle electrode is then connected to an pulse generator which delivers an adjustable electrial pulse that travels to the sacral plexus in the spine via the tibial nerve. Among other functions, the sacral nerve plexus regulates bladder and pelvic floor function.

PTNS has very few side effects: tingling/mild discomfort around the ankle, mild redness/inflammation around the ankle, numb toes & mild stomach ache.

NB: PTNS is available on the NHS.

ClinicSpeak: eHealth MS portal using Microsoft HealthVault

Time to relaunch an old initiative: an eMedicine portal to help you self-manage MS using HealthVault. #ClinicSpeak #MSBlog #MSResearch

"The article below presents compelling data that telemedicine is feasible and doable in the MS space. More importantly the pilot study shows that telecare is a useful tool for monitoring MSers at home, and has the potential to improve health care while reducing costs, and could be extended to  the management of other chronic neurological diseases."

"Recently at the ENS-EFNS meeting in Istanbul I gave a talk on eHealth. I was invited to speak due to my involvement in social media. I gave the talk below which is essentially an adaptation of my scocial media talk. However, preparing and delivering the talk made me ruminate and play around with an idea that I have had for several years to create an eMedicine portal to help MSers self-manage their disease with intermittent and targeted help from their MS team. When I costed the IT development cost it was prohibitive, not to mention the medico-legal issues regarding confidentiality, privacy, etc. This has all changed for me with Microsoft's launch of HealthVault. "

"HealthVault is a cloud-based service where you store and log all your healthcare information and link it to compatible healthcare devices. HealthVault allows you to upload results of investigations, including MRI scans and other imaging files. You can then securely share your HealthVault or limited sections of your HealthVault with your neurologist or MS nurse so that they can make comments or give advice.  Microsoft HealthVault also has the ability to interface with Healthcare Apps so that data from the Apps are automatically uploaded into your vault. 

As we are continuously getting requests for opinions from MSers from all over the world; including parts of the world with poor access to MS expertise. Due to privacy and medico-legal issues we can't respond by using regular emails and it is difficult to review investigations and MRI scans via email. Hence my colleagues and I want to test Microsoft HealthVault as a portal for eMedicine consultations. Why Microsoft HealthVault? Simple, it already exists, is controlled by you and it is free.  Microsoft HealthVault has also cleared all the necessary data protection and data encryption hurdles and it has even been given the green-light by the NHS and other healthcare providers."

"We have been in discussion with a software developer to design a MS self-monitoring app that will interface with Microsoft HealthVault that will allow you to track your disease. Our interest in HealthVault is the ability to use it for research. Before writing a grant to get money to develop a HealthVault MS App we want to test out the feasibility of using HealthVault for eMedicine consultations, for monitoring MS, the user experience and the procedures require to make this work. To achieve this we are looking for a few volunteers to test the waters. I hope some of you will are interested?"

"Microsoft HealthVault has the potential to empower individual MSers and revolutionize personal healthcare. Microsoft are encouraging healthcare and software developers to develop Apps for HealthVault and as far as I am concerned the sky is the limit in terms of what can be achieved in the MS space. I think it is time to join the eMedicine revolution. Do you?"

Zissman et al. Telemedicine for multiple sclerosis patients: assessment using Health Value Compass. Mult Scler. 2012 Apr;18(4):472-80. doi: 10.1177/1352458511421918. Epub 2011 Sep 30.

Background: Telemedicine carries the potential of improving accessibility to health services, especially for disabled people.

Objective: To assess the health-related outcomes of short-term implementation of telemedicine (telemed) for MSers.

Methods: A prospective study of 40 MSers divided into a control group and a telemed group was conducted, in two stages: A. Six months’ follow-up for measurement of baseline health-related variables; B. Implementation stage, adding home telecare to the telemed group. A Health Value Compass was applied to assess the outcomes of home telecare implementation. Clinical status, cost data, patients’ self-assessment of Health Related Quality of Life (HRQoL) and satisfaction with telecare were studied.

Results: MSers in the telemed group demonstrated improved clinical outcome measured by symptoms severity. There was a decrease of at least 35% in the medical costs for 67% of the telemed group patients. Satisfaction with telecare was high and most MSers would recommend this service to others.

Conclusions: The present pilot study, applying Health Value Compass-based analysis, suggests that telecare is a powerful tool for monitoring MSers at home, carries the potential to improve health care while reducing costs, and should be considered for implementation as part of the management of chronic neurological diseases.

Treatment as Onset can slow development of MS

Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; for the TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis(TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 . pii: S1474-4422(14)70191-7

BACKGROUND: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis. We aimed to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of multiple sclerosis.
METHODS: In this randomised, double-blind, placebo-controlled, parallel-group study, we enrolled patients aged 18-55 years with clinically isolated syndrome (defined as a neurological event consistent with demyelination, starting within 90 days of randomisation, and two or more T2-weighted MRI lesions ≥3 mm in diameter) from 112 centres (mostly hospitals) in 20 countries. Participants were randomly assigned (1:1:1) in a double-blind manner (by an interactive voice response system) to once-daily oral teriflunomide 14 mg, teriflunomide 7 mg, or placebo, for up to 108 weeks. Patients, staff administering the interventions, and outcome assessors were masked to treatment assignment. The primary endpoint was time to relapse (a new neurological abnormality separated by ≥30 days from a preceding clinical event, present for ≥24 h in the absence of fever or known infection), which defined conversion to clinically definite multiple sclerosis. The key secondary endpoint was time to relapse or new gadolinium-enhancing or T2 lesions on MRI, whichever occurred first. The primary outcome was analysed for the modified intention-to-treat population; safety analyses included all randomised patients who were exposed to the study drug, as treated. This trial is registered with, number NCT00622700.
FINDINGS: Between Feb 13, 2008, and Aug 22, 2012, 618 patients were enrolled and randomly assigned to teriflunomide 14 mg (n=216), teriflunomide 7 mg (n=205), or placebo (n=197). Two patients in each of the teriflunomide groups did not receive the study drug, so the modified intention-to-treat population comprised 214 patients in the teriflunomide 14 mg group, 203 in the teriflunomide 7 mg group, and 197 in the placebo group. Compared with placebo, teriflunomide significantly reduced the risk of relapse defining clinically definite multiple sclerosis at the 14 mg dose (hazard ratio [HR] 0·574 [95% CI 0·379-0·869]; p=0·0087) and at the 7 mg dose (0·628 [0·416-0·949]; p=0·0271). Teriflunomide reduced the risk of relapse or a new MRI lesion compared with placebo at the 14 mg dose (HR 0·651 [95% CI 0·515-0·822]; p=0·0003) and at the 7 mg dose (0·686 [0·540-0·871]; p=0·0020). During the study, six patients who were randomly assigned to placebo accidently also received teriflunomide at some point: four received 7 mg and two received 14 mg. Therefore, the safety population comprised 216 patients on teriflunomide 14 mg, 207 on teriflunomide 7 mg, and 191 on placebo. Adverse events that occurred in at least 10% of patients in either teriflunomide group and with an incidence that was at least 2% higher than that with placebo were increased alanine aminotransferase (19% 14mg, [17% in 7 mg group vs 14% in the placebo group), hair thinning (12% 14mg/ 6% 7mg/8% placebo), diarrhoea (11%/14%/ vs 6% placebo), paraesthesia (22 [10%] and 11 [5%] vs 10 [5%]), and upper respiratory tract infection (20 [9%] and 23 [11%] vs 14 [7%]). The most common serious adverse event was an increase in alanine aminotransferase (four [2%] and five [2%] vs three [2%]).
INTERPRETATION: TOPIC is to our knowledge the first study to report benefits of an available oral disease-modifying therapy in patients with early multiple sclerosis. These results extend the stages of multiple sclerosis in which teriflunomide shows a beneficial effect.

ProfG or NeuroDocG may comment on this further but this trial reports on the effect of giving aubagio (teriflunamide). In this study aubagio was given to people with clinically isolated syndrome and reduced the risk of getting additional attacks and converting to MS by about 40%, The risks were associated with digestive problems and hair thinning. Aubagio is similar in activity to the beta interferons but have the advantage of being a pill. In UK treatment at CIS needs evidence of disease being MS, suvh as with MRI lesions. However, this current study shows that if you treat early then you can have an therapeutic effect, however we can do better. This is not the first study of an oral effective agent in clinically isolated syndrome as movectro, which was temporary available in Australia and Russia was tested and slowed the conversion rate by about 70%. Therefore one may suspect that the "available" DMT that are more effective than aubagio may have greater efficacy however it is up to the manufacturers to prove it.

CoI: None