Bladder DysfunctionNCT04528784
Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis
A study testing Transcutaneous tibial nerve stimulation in people with Bladder Dysfunction and Neurogenic Bladder Dysfunction, run by University of Limerick at 1 site in Ireland.
Trial summary
Neurogenic lower urinary tract dysfunction is common among people with Multiple sclerosis with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Dysfunction, Neurogenic Bladder Dysfunction, Urinary Incontinence
- What is being tested?
- Transcutaneous tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIreland
- Study dates
- 14 Oct 2020to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported diagnosis of any type of Multiple Sclerosis
- Male or female
- Aged ≥18 years old
- Ambulatory
- At least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence).
Who cannot join
- People with an indwelling urethral catheter or indwelling suprapubic catheter
- Urologic disease including bladder malignancy
- Diabetic mellitus
- Pregnant women or planning to be pregnant during the study time
- Recent pelvic related surgery <1 year
- Pacemaker or other metallic internal devices
- Urinary tract infections (UTIs) during recruitment phase.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Tibial Nerve Stimulation for the Treatment of Bladder Storage Symptoms in People With Multiple Sclerosis: Protocol of a Single-arm Feasibility Study
Neurogenic lower urinary tract dysfunction is common among people with Multiple sclerosis with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive treatment option to manage bladder storage symptoms, however, the potential efficacy of TTNS among people with multiple sclerosis is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. The feasibility and acceptability of TTNS to manage storage bladder symptoms using Transcutaneous Electrical Nerve Stimulation (TENS) needs to be established before proceeding with a definitive randomised trial. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS
Read the detailed description
The investigators will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in multiple sclerosis. The CONSORT extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. The recruitment plan is twofold: 1) Open recruitment for people with MS through MS Ireland's communication channels; 2) Recruitment from a convenience sample of people with MS who have previously participated in a qualitative study. The investigators will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life using International classification of incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events and acceptability of using TTNS.
- Conditions
- Bladder Dysfunction, Neurogenic Bladder Dysfunction, Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Nocturia
- Being tested
- Transcutaneous tibial nerve stimulation
- Keywords
- Multiple sclerosis, Neurogenic bladder, Feasibility study, Tibial nerve stimulation
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Nocturia, Lower Urinary Tract Symptoms, Multiple Sclerosis, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous tibial nerve stimulationDevice
Also called Stimulation of tibial nerve.
Transcutaneous tibial nerve stimulation is a non-invasive electrical stimulation of the posterior tibial nerve, a branch of the sciatic nerve via sacral plexus. In our study the tibial nerve will be stimulated using Transcutaneous Electrical Nerve Stimulation (TENS) unit with two surface adhesive electrodes. The anode will be positioned between 5-10 cm above medial malleolus and posterior to the edge of the tibia and the cathode will be positioned distally on arch of the foot .
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Transcutaneous tibial nerve stimulation will be applied as follows: 18 sessions of 30 minutes duration, delivered three times a week over a 6 week period using TENS device with 10 Hertz (Hz), and pulse width 200µs. The intensity of stimulation will be at the sensory and motor threshold by tingling sensation on sole of the foot with flexion of big toe and /or fanning of other toes. Receives: Device: Transcutaneous tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate/ retention rate
The proportion of participants who are recruited to the study and the proportion of participants who are lost to follow up
Measured: 6 weeks
Adherence rate
The proportion of participants who adhere to the treatment protocol of 6 weeks
Measured: 6 weeks
Adverse events
Number of participants with adverse events as a measure of safety
Measured: 6 weeks
Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable
The proportion of participants with MS reporting that TTNS is acceptable.
Measured: 6 weeks
Secondary outcomes (4)
International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)
Changes in the severity of scores for bladder storage symptoms experienced by participants measured using ICIQ-OAB. It has grade A for validity, reliability and responsiveness to change established with rigour on one data set. The total score ranges from 0 to 16 with higher values indicating increased symptom severity. Bother scales are not incorporated in the overall score.
Measured: 6 weeks
Kings Health Questionnaire
Changes in scores for the effect of urinary symptoms in activity of daily living measured by the Kings Health Questionnaire. Each domain within the Kings Health Questionnaire is scored on a 0 (best) to 100 (worst) scale. A change from baseline of 5 points or higher on most of the King's Health Questionnaire domains represents a clinically meaningful improvement in health-related quality of life after treatment.
Measured: 6 weeks
3- day bladder diary
Number of episodes of frequency, nocturia, and incontinence/ 72 hours will be calculated and compared from baseline with higher values indicating increased symptom severity.
Measured: 6 weeks
Patient Perception of Intensity of Urgency Scale
Number of urgency episodes and severity of urgency/72 hours will be calculated and compared from baseline. The total score ranges from 0 to 4 with higher values indicating increased symptom severity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start14 Oct 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm feasibility study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Robinson, University of Limerick
- Investigators
- Katie Robinson, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528784
- Sponsor's protocol ID
- TTNS in MS
- Status last verified
- Apr 2021
- First submitted
- 17 Aug 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis. Pilot Feasibility Stud. 2022 Jul 30;8(1):161. doi: 10.1186/s40814-022-01120-1.
PubMed 35908067Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study. HRB Open Res. 2020 Sep 16;3:66. doi: 10.12688/hrbopenres.13107.1. eCollection 2020.
PubMed 33117961
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation for the Treatment of Bladder Storage Symptoms in People With Multiple Sclerosis: Protocol of a Single-arm Feasibility Study
- ClinicalTrials.gov ID
- NCT04528784
- Acronym / sponsor ID
- TTNS in MS
- Conditions
- Bladder Dysfunction, Neurogenic Bladder Dysfunction, Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Nocturia
- Keywords
- Multiple sclerosis, Neurogenic bladder, Feasibility study, Tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurogenic lower urinary tract dysfunction is common among people with Multiple sclerosis with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive treatment option to manage bladder storage symptoms, however, the potential efficacy of TTNS among people with multiple sclerosis is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. The feasibility and acceptability of TTNS to manage storage bladder symptoms using Transcutaneous Electrical Nerve Stimulation (TENS) needs to be established before proceeding with a definitive randomised trial. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS
Detailed description
The investigators will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in multiple sclerosis. The CONSORT extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. The recruitment plan is twofold: 1) Open recruitment for people with MS through MS Ireland's communication channels; 2) Recruitment from a convenience sample of people with MS who have previously participated in a qualitative study. The investigators will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life using International classification of incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events and acceptability of using TTNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Transcutaneous tibial nerve stimulationTranscutaneous tibial nerve stimulation will be applied as follows: 18 sessions of 30 minutes duration, delivered three times a week over a 6 week period using TENS device with 10 Hertz (Hz), and pulse width 200µs. The intensity of stimulation will be at the sensory and motor threshold by tingling sensation on sole of the foot with flexion of big toe and /or fanning of other toes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported diagnosis of any type of Multiple Sclerosis
- Male or female
- Aged ≥18 years old
- Ambulatory
- At least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence).
Key exclusion criteria (7 listed)
- People with an indwelling urethral catheter or indwelling suprapubic catheter
- Urologic disease including bladder malignancy
- Diabetic mellitus
- Pregnant women or planning to be pregnant during the study time
- Recent pelvic related surgery <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous tibial nerve stimulationAlso: Stimulation of tibial nerve.Transcutaneous tibial nerve stimulation is a non-invasive electrical stimulation of the posterior tibial nerve, a branch of the sciatic nerve via sacral plexus. In our study the tibial nerve will be stimulated using Transcutaneous Electrical Nerve Stimulation (TENS) unit with two surface adhesive electrodes. The anode will be positioned between 5-10 cm above medial malleolus and posterior to the edge of the tibia and the cathode will be positioned distally on arch of the foot . | Device | Intervention |
Primary outcome
Recruitment rate/ retention rate
Time frame: 6 weeks
The proportion of participants who are recruited to the study and the proportion of participants who are lost to follow up
Adherence rate
Time frame: 6 weeks
The proportion of participants who adhere to the treatment protocol of 6 weeks
Adverse events
Time frame: 6 weeks
Number of participants with adverse events as a measure of safety
Acceptability of using TTNS: proportion of participants with MS reporting that TTNS is acceptable
Time frame: 6 weeks
The proportion of participants with MS reporting that TTNS is acceptable.
4 secondary outcomes
International Consultation of Incontinence Questionnaire-Overactive bladder (ICIQ-OAB)
Time frame: 6 weeks
Kings Health Questionnaire
Time frame: 6 weeks
3- day bladder diary
Time frame: 6 weeks
Patient Perception of Intensity of Urgency Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 35908067Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis. Pilot Feasibility Stud. 2022 Jul 30;8(1):161. doi: 10.1186/s40814-022-01120-1.
- Derived from this study: PubMed 33117961Al Dandan HB, Galvin R, Robinson K, McClurg D, Coote S. Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study. HRB Open Res. 2020 Sep 16;3:66. doi: 10.12688/hrbopenres.13107.1. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Robinson, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous tibial nerve stimulation in people with Bladder Dysfunction and Neurogenic Bladder Dysfunction, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate/ retention rate (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528784, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.