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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790307
• Other study ID #: 12/LO/1613
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2016
• Last updated: May 31, 2016
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• The Geko
transcutaneous tibial nerve stimulation (stick on patch)

Locations

Country	Name	City	State
United Kingdom	National Hospital for Neurology and Neurosurgery	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

de Sèze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Gamé 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting adverse events as recorded using a customised diary	Adverse events are recorded by patients using a compliance diary	12 weeks	Yes
Secondary	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	12 weeks	No