NCT03248362

Brief Summary

This study aims to determine whether a programme of transcutaneous posterior tibial nerve stimulation (TPTNS) is a clinically effective treatment for urinary incontinence (UI) in care home residents and what the associated costs and consequences are.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 10, 2020

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

August 1, 2017

Last Update Submit

January 8, 2020

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Volume of UI leaked

    Volume of UI leaked over a 24 hour period

    6 weeks post randomisation.

Secondary Outcomes (10)

  • Pad use

    6, 12 and 18 weeks post randomisation

  • PVRU volume

    6, 12 and 18 weeks post randomisation

  • PBBC

    6, 12 and 18 weeks post randomisation

  • FC-PBC

    6, 12 and 18 weeks post randomisation

  • S-PBC

    6, 12 and 18 weeks post randomisation

  • +5 more secondary outcomes

Study Arms (2)

TPTNS Intervention

EXPERIMENTAL

Transcutaneous posterior tibial nerve stimulation (TPTNS) delivered in 30 minute sessions twice weekly over a 6 week period. The tibial nerve, which lies immediately posterior to the medial malleolus will be stimulated electrically using a portable TENS machine and two surface electrodes. The cathode electrode will be positioned behind the medial malleolus and the anode 10cm cephalad to it. Standardised stimulation parameters will be applied at 10 Hz frequency, 200µs-1 pulse width in continuous mode and stimulation intensity (mA-1) will be adjusted on a session-by-session basis according to individual resident comfort levels.

Device: Transcutaneous posterior tibial nerve stimulation

Sham stimulation

SHAM COMPARATOR

Sham stimulation comprises low intensity, sub-clinical stimulation of the lateral sub-malleolar area, positioned specifically on the lateral aspect to avoid the tibial nerve, which runs close to the skin surface behind the medial malleolus. The stimulation parameters are identical to the TPTNS stimulation other than the intensity of the current which will be set at 4mA, rather than adjusted individually as it is in the TPTNS intervention group. The current will be initially increased until the resident reports feeling some sensation following which the current will be reduced down to 4mA. All residents will be informed that they may not feel anything with this intervention and that this is quite normal.

Device: Sham stimulation

Interventions

Transcutaneous posterior tibial nerve stimulationDEVICE

12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation

TPTNS Intervention
Sham stimulationDEVICE

12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of of the lateral sub-malleolar area

Sham stimulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Care home residents:
  • with self or staff reported UI of more than once/week
  • who use the toilet or toilet aid for bladder evacuation with or without assistance
  • who wear absorbent pads to contain UI.

You may not qualify if:

  • Care home residents:
  • with an indwelling urinary catheter
  • residents with UTI
  • residents with PVRU volume more than 300ml
  • residents with a cardiac pacemaker
  • residents with treated epilepsy
  • residents with bilateral leg ulcers
  • residents with pelvic cancer
  • residents on the palliative care register

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Caledonian University

Glasgow, G4 0BA, United Kingdom

Location

Related Publications (4)

  • Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.

    PMID: 23206722BACKGROUND

  • Fenocchi L, Mason H, Macaulay L, O'Dolan C, Treweek S, Booth J. Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial. BMC Geriatr. 2023 Nov 22;23(1):766. doi: 10.1186/s12877-023-04459-z.

    PMID: 37993786DERIVED

  • Booth J, Aucott L, Cotton S, Davis B, Fenocchi L, Goodman C, Hagen S, Harari D, Lawrence M, Lowndes A, Macaulay L, MacLennan G, Mason H, McClurg D, Norrie J, Norton C, O'Dolan C, Skelton D, Surr C, Treweek S. Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT. Health Technol Assess. 2021 Jun;25(41):1-110. doi: 10.3310/hta25410.

    PMID: 34167637DERIVED

  • Booth J, Aucott L, Cotton S, Goodman C, Hagen S, Harari D, Lawrence M, Lowndes A, Macaulay L, MacLennan G, Mason H, McClurg D, Norrie J, Norton C, O'Dolan C, Skelton DA, Surr C, Treweek S. ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial. Trials. 2019 Dec 16;20(1):723. doi: 10.1186/s13063-019-3723-7.

    PMID: 31843002DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joanne Booth, Prof

    Glasgow Caledonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants \& primary researchers will be blinded to group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A pragmatic, multicentre, placebo controlled randomised parallel group trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 14, 2017

Study Start

January 29, 2018

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

January 10, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)