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

NCT02377765 | Completed

• 1 other identifier: LWH0991
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Overactive Bladder

Keywords

Neuromodulation; Detrusor overactivity; Urinary urgency; Urgency urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Changes in 24-hour micturition frequency

  Mean number of micturition episodes recorded in 3-day bladder chart.

  Bladder diaries completed at recruitment and 6 weeks, 12 weeks and 6 months.

Secondary Outcomes (2)

• Symptom severity

  OAB-q completed at recruitment and 6 weeks, 12 weeks and 6 months.

• Health Related Quality of Life

  OAB-q completed at recruitment and 6 weeks, 12 weeks and 6 months.

Study Arms (2)

Percutaneus Stimulation

ACTIVE COMPARATOR

PTNS performed bilaterally every 4 weeks within the Physiotherapy Department.

Procedure: Percutaneus Stimulation

Transcutaneous Stimulation

EXPERIMENTAL

TPTNS applied bilaterally, using two surface, self-adhesive, round electrodes (3 cm in diameter) in each leg at least 3 times per week.

Device: Transcutaneous Stimulation

Interventions

Transcutaneous Stimulation DEVICE

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.

Transcutaneous Stimulation

Percutaneus Stimulation PROCEDURE

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).

Percutaneus Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female.
• Over 18 years of age.
• Clinically diagnosed of idiopathic OAB according to the definition by the International Continence Society (Haylen et al, 2012) given above.
• Good response to PTNS. For the purpose of this study, responders will be considered those subjects who have achieved a reduction in the number of micturitions per 24 hours by \> 30%.
• Able and willing to give informed consent.

You may not qualify if:

• Patients who do not comprehend the physiotherapist's instructions or who are unable to co-operate.
• Pregnancy, or plans of becoming pregnant during the course of the study. The main acupuncture point that will be used (SP6) has been reported to induce uterine activity (Hecker et al, 2001).
• Presence of a relevant neurological condition (causing neurogenic detrusor overactivity or peripheral neuropathy).
• Previous history of continence surgery.
• Women with a pace-maker fitted.
• Women with uncorrectable coagulopathies or on anticoagulant medication.
• Presence of dermatological lesions (e.g. dermatitis, eczema...) in the medial aspect of lower leg and/or feet.
• No anticholinergic medication will be allowed during the study period with minimum wash-out period of 15 days before randomization.

Sponsors & Collaborators

• Liverpool Women's NHS Foundation Trust: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

Liverpool Women's Hospital

Liverpool, L8 7SS, United Kingdom

Location

Related Publications (1)

• Martin-Garcia M, Crampton J. A single-blind, randomized controlled trial to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in Overactive Bladder symptoms in women responders to percutaneous tibial nerve stimulation (PTNS). Physiotherapy. 2019 Dec;105(4):469-475. doi: 10.1016/j.physio.2018.12.002. Epub 2018 Dec 18.

  PMID: 30862384 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Miguel Martin-Garcia, MSc

  Liverpool Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 20, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)