Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis

NCT ID: NCT04528784

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2021-03-12

Brief 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. 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.

Conditions

Bladder Dysfunction; Neurogenic Bladder Dysfunction; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Nocturia; Urinary Frequency More Than Once at Night; Lower Urinary Tract Symptoms; Multiple Sclerosis; Urinary Bladder, Neurogenic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Transcutaneous tibial nerve stimulation

Intervention Type: DEVICE

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 .

Interventions

Transcutaneous tibial nerve stimulation

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 .

Intervention Type: DEVICE

Other Intervention Names

Stimulation of tibial nerve.

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Katie Robinson

Senior lecturer, Occupational therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katie Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

University of Limerick

Limerick, LK, Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 35908067 (View on PubMed)

Al 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.

Reference Type: DERIVED

PMID: 33117961 (View on PubMed)

Other Identifiers

TTNS in MS

Identifier Type: -

Identifier Source: org_study_id