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A Feasibility Study of Adjunct Transcutaneous Electric Stimulation in Post-stroke Incontinence Rehabilitation

A Feasibility Study of Adjunct Transcutaneous Electric Stimulation in Post-stroke Incontinence Rehabilitation

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000879864
Acronym
NIl
Enrollment
1
Registered
2021-07-07
Start date
2022-08-08
Completion date
2022-08-08
Last updated
2023-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Certain Transcutaneous Electric Nerve Stimulation (TENS) machines are approved to be used in Australia to treat incontinence, however, it is not known if it is useful for people who have just had a stroke. In this study, the investigators aim to see if it is feasible and acceptable to use TENS in addition to standard treatments for incontinence after a stroke. Participation will involve trying two TENS treatment protocols and one sham TENS protocol. Participants are to learn one protocol on one day and then given a chance to perform the protocol while being observed by the investigator on the following day. The investigators hypothesise that adults can learn and safely perform TENS protocols for post-stroke incontinence.

Interventions

The two TENS intervention protocols that will be assessed for safety and feasibility are: Posterior Tibial Nerve TENS – With the appropriate level of assistance and supervision from carers, the participant will assume sitting or lying position with the legs extended. An alcohol swab is used to cleanse the site from excess oil or moisture. The positive electrodes are attached on the medial malleolus and the negative electrodes are attached 10 cm (1 palm-width) above. The TENS machine with a lock

The two TENS intervention protocols that will be assessed for safety and feasibility are: Posterior Tibial Nerve TENS – With the appropriate level of assistance and supervision from carers, the participant will assume sitting or lying position with the legs extended. An alcohol swab is used to cleanse the site from excess oil or moisture. The positive electrodes are attached on the medial malleolus and the negative electrodes are attached 10 cm (1 palm-width) above. The TENS machine with a locked pre-set of 10 Hz frequency and 200µs pulse width is turned on and the participant will increase the intensity to a maximum comfortable level below the threshold that causes motor contraction of the toes. The participant ensures that there is no pain or discomfort associated with the therapy. The therapy is delivered for 30 minutes and then the TENS machine is turned off. Parasacral TENS – With the appropriate level of assistance and supervision from carers, the participant will lie down with a towel across the hips. Using the towel to maintain privacy, the pants and undergarments are lowered and the participant assumes a side-lying position with the knees bent. An alcohol swab is used to cleanse the site from excess oil or moisture. The positive electrodes are placed on opposite sides of the second sacral spine and the negative electrodes on the inside of the middle and lower third of the junction between the posterior superior iliac spine and the ischial node. The participant then lies down on supine position and the TENS machine with a locked pre-set of 20 Hz frequency and 150µs pulse width is turned on. The participant will increase the intensity to a maximum comfortable level. The participant ensures that there is no pain or discomfort associated with the therapy. The therapy is delivered for 30 minutes and then the TENS machine is turned off. Participants will be taught the TENS protocol on one day and then given a chance to perform the protocol while being observed by the investigator on the following day. During the observed practice session, the investigator will use an observation checklist to record if the participant required further support and what assistance was needed to perform the TENS protocol. The participant flow through the study is expected to be completed in 4 days. An example of participant flow is as follows: Day 1 - Learn posterior tibial TENS Day 2 - Perform posterior tibial TENS then learn parasacral TENS Day 3 - Perform parasacral TENS then learn sham (shoulder) TENS Day 4 - Perform sham TENS Randomisation will be done to determine the order of TENS protocols that participants are to try. There is no wash-out period involved in this safety and feasibility study.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(1) aged 18 years and older, (2) diagnosis of acute stroke < 7 days from recruitment, (3) identified as having new urinary or faecal incontinence by the interdisciplinary team

Exclusion criteria

(1) implanted electrical devices such as pacemakers or defibrillators, (2) episode of seizures within 24 hours prior to recruitment, (3) allergy to latex or adhesives, (4) pre-existing incontinence that persisted to the month of stroke event, (5) non-English speaker, (6) no means to respond to questions effectively (patients with new communication difficulties are not necessarily excluded for as long as they have a way to respond to questions such as using a communication board), (7) urinary or faecal diversion, (8) pregnant, (9) neuromuscular or dermal condition affecting the ankles, buttocks or shoulders, (10) active malignant disease, (11) no Medicare, (12) no means to use a TENS machine (patients who may require assistance to use a TENS machine are not necessarily excluded for as long as they are able to ask for the assistance they require), (13) concomitant participation in acute stroke trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026