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

May 31, 2016 updated by: Jalesh Panicker, University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • National Hospital For Neurology and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily stimulation (30mins/day)
30 minutes daily for 12 weeks of Tibial nerve stimulation using the Geko device
Device: The Geko
transcutaneous tibial nerve stimulation (stick on patch)
Experimental: Weekly stimulation (30mins/week)
30 minutes daily for 12 weeks of Tibial nerve stimulation using the Geko device
Device: The Geko
transcutaneous tibial nerve stimulation (stick on patch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants reporting adverse events as recorded using a customised diary
Time Frame: 12 weeks
Adverse events are recorded by patients using a compliance diary
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in overactive bladder symptoms as evaluated using a Global Response Assessment (GRA) scale
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Jalesh Panicker, FRCP, National Hospital For Neurology and Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/LO/1613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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