A Phase 2 interventional study of The Geko in Overactive Bladder and Multiple Sclerosis, sponsored by University College, London. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2016-06-03.
Sponsored by University College, London · Phase 2, Interventional, and Treatment
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.
In this single centre pilot study, 48 patients with OAB (24 with neurogenic and 24 with idiopathic OAB) were randomized to use a self-applicating ambulatory skin-adhering device to transcutaneously stimulate the tibial nerve for 30 minutes, either once daily or once weekly, for 12-weeks. Changes in lower urinary tract (LUT) OAB symptoms and QoL were measured at baseline, weeks 4, 8, and 12 using standardized validated scoring instruments (ICIQ-OAB and ICIQ-LUTSqol) and a Global Response Assessment (GRA) at week 12. Weekly phone calls and a usage diary captured patient-reported experiences with the device and compliance.
The primary study outcomes were to assess safety and acceptability of the device. In addition, treatment response was assessed using the Global Response Assessment (GRA) at week-12, and the International Consultation on Incontinence Questionnaire Overactive Bladder and LUTS-quality of life (ICIQ-OAB and ICIQ-LUTSqol) at baseline, week 4, 8 and 12. In the GRA patients were asked to assess their response to treatment using an ordinal scale of 0 to 3, referring to none, mild, moderate or marked improvement, respectively 1. Patients reporting moderate or marked improvement were considered to have responded to treatment 1. The ICIQ-OAB score is a 4-item questionnaire that assesses OAB symptom severity and bother whereas the ICIQ-LUTSqol score is a 20-item health related quality of life questionnaire. In both questionnaires, part A assesses symptom severity and part B reflects the accumulative bother to the patient. High scores suggests worse symptom profiles and negative impact on QoL, respectively.
Patients recorded use of the device in a customized compliance diary which also included entries for their experiences in using the device and any adverse effects. Additionally, weekly phone calls were made by a member of the research team to assess compliance.
Statistical analysis A feasibility sample size of 48 patients was adopted and no formal power calculation was performed as is the convention for pilot studies. All data were presented as means with SDs. Paired student t-tests were used to provide an estimate of within group responses between baseline and 12 weeks.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 minutes daily for 12 weeks of Tibial nerve stimulation using the Geko device
Device: The Geko
30 minutes daily for 12 weeks of Tibial nerve stimulation using the Geko device
Device: The Geko
transcutaneous tibial nerve stimulation (stick on patch)
Number of participants reporting adverse events as recorded using a customised diary
Adverse events are recorded by patients using a compliance diary
Time frame: 12 weeks
Improvement in overactive bladder symptoms as evaluated using a Global Response Assessment (GRA) scale
The Global Response Assessment (GRA) scale assesses the response to treatment using an ordinal scale of 0 to 3, referring to none, mild, moderate or marked improvement, respectively
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University College, London