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Use of Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) in Maintaining OAB Symptoms Improvement.

NCT02377765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-10-20

No results posted yet for this study

Summary

This study will help to determine the effectiveness of a self-supervised, home-based Transcutaneous Posterior Tibial Nerve Stimulation treatment protocol in maintaining Overactive Bladder (OAB) symptoms improvement in women responders to Posterior Tibial Nerve Stimulation (PTNS)

Conditions

Interventions

DEVICE

Transcutaneous Stimulation

TPTNS through a TENS unit is a non-invasive technique, easily manageable by patients, which lacks some adverse side effects reported with the use of PTNS, such as bleeding and/or pain at the site of needle insertion. As the technique is self-administered, the associated costs might be substantially lower when compared to PTNS, which involves repeated Hospital appointments for maintenance therapy.

PROCEDURE

Percutaneus Stimulation

PTNS aims to stimulate the sacral nerve plexus (origin to the parasympathetic innervations to the bladder) through the afferent fibres of the posterior tibial nerve, a mixed nerve containing L5-S3 fibres (Slovak, Chapple and Barker, 2014). This is achieved by a needle electrode inserted above the medial malleolus. Interestingly, this anatomical area is known as acupuncture point Spleen6 (Sp6).

Sponsors & Collaborators

  • Manchester Metropolitan University

    collaborator OTHER

  • Liverpool Women's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Miguel Martin-Garcia, MSc · Liverpool Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02377765 on ClinicalTrials.gov