Transcutaneous Tibial Nerve Stimulation of Patients With Overactive Bl
Single Centre Randomised Pilot Study of Two Regimens (30mins Daily or Weekly for 12 Weeks) of Transcutaneous Tibial Nerve Stimulation of Patients With Overactive Bladder (OAB) Syndrome
What it found
We found no results in the registry or in papers.
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- The Geko
What it measured
Main measures
Number of participants reporting adverse events as recorded using a customised diary
12 weeks
Safety
Other measures (1)
Improvement in overactive bladder symptoms as evaluated using a Global Response Assessment (GRA) scale
12 weeks
Bladder, bowel and sexual function
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
* Patient eligibility was based on meeting the criteria for an overactive bladder, defined by the International Continence Society with an average urinary frequency ≥ 8 voids per and ≥ 1 urgency episode (with or without incontinence) per 24 hours
Exclusion criteria
* Exclusion criteria included use of botulinum toxin A treatment within the previous year or neuromodulation (TNS or sacral neuromodulation), patients with sensory loss in the gaitor region (based on intact cutaneous sensation to nociception in the lower limb), presence of urinary tract infection or any other documented LUT pathology
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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, acceptability and pilot efficacy of transcutaneous TNS using a novel device.
Papers
Background
Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.Background
de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.
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History
Started
Jan 2013
Main results due
Sept 2013
Finished
Dec 2013