Impact of TTNS on Bladder Symptoms Among People With MS, A RCT

NCT06341673 | Recruiting DMC

• 1 other identifier: IRB-2023-O3-442
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis (MS). Recent studies showed that bladder storage symptoms are predominant among MS with a pooled prevalence of frequency at 73.45% followed by urgency at 63.87%. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment to manage bladder storage symptoms; however, the effectiveness of TTNS is based on a small number of studies with the absence of high-quality evidence. This study aims to investigate the effectiveness of TTNS on bladder storage symptoms compared with sham TTNS among people with MS.Methods: The investigators will use a randomised sham controlled double blind study to explore the effectiveness of TTNS in the treatment of bladder storage symptoms in MS. the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to standardize the conduct and reporting of the current protocol. The recruitment plan is twofold: 1) Open recruitment for people with MS through King Fahd Hospital of the University communication channels; 2) people with any type of MS attending their routine appointments in MS clinic at King Fahd Hospital of the University, Al Khobar. The investigators will investigate the effectiveness of TTNS compared to sham TTNS on bladder storage symptoms and the effect on quality of life using ICIQ-OAB, ICIQ 3-day bladder diary, ICIQ-LUTS qol, and PSQI. Participant's perception of change post intervention will be evaluated using GPE. Outcomes will be measured at 0, 6 weeks and at 6 months post intervention. A sample size of 72 patients (36 in each group) is required to achieve 90% power with two-tailed tests at an alpha level of 0.05. Conclusion: Multiple sclerosis is a long-term condition, and self-management is important. TTNS provide a safe, non-invasive intervention that can be administered at home. Should the trial determine that TTNS is effective compared to sham TTNS, the investigators will plan to integrate TTNS into standard clinical care pathways in MS.

Conditions

Overactive Bladder Syndrome

Keywords

Multiple Sclerosis; Overactive bladder; Bladder storage symptoms; Incontinence; Tibial nerve stimulation; Stimulation

Outcome Measures

Primary Outcomes (3)

• The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB)

  Patient-completed questionnaire to measure urinary frequency, urgency, and nocturia. The total score ranges from 0 to 16 with higher values indicating increased symptom severity. Bother scales are not incorporated in the overall score.

  2 months

• 3- day Bladder diary

  Patient-completed diary for 72 hours. Number of episodes of urinary frequency, nocturia, and incontinence/ 72 hours will be calculated and compared from baseline with higher values indicating increased symptom severity.

  2 months

• Urinary sensation 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.

  2 months

Secondary Outcomes (3)

• The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol)

  2 months

• Pittsburgh Sleep Quality Index (PSQI)-item 6

  2 months

• Global Perceived Effect (GPE) Scale

  2 months

Study Arms (2)

Transcutaneous Electrical Nerve Stimulation: Transcutaneous Tibial Nerve Stimulation

ACTIVE COMPARATOR

Participants will useTENS to stimulate tibial nerve on the medial side of the foot for 6 weeks, a total of 18 sessions, three times weekly for 30 minutes per session. All TENS units will be programmed and locked by principal investigator to ensure fixed stimulation parameters are used among participants throughout the study intervention. The stimulation frequency will be set at 10 Hz with a pulse duration 200 μs. Participants will be advised to apply the stimulation in a supine position or supported sitting with extended legs to avoid compression of nerve roots at the knee joint. Participants will place the stimulation electrode, the negative electrode, between 5 and 10 cm above the medial malleolus and the positive electrode behind the left medial malleolus.

Device: Active Transcutaneous Electrical Nerve Stimulation (TENS)

Sham arm: Transcutaneous Electrical Nerve Stimulation

SHAM COMPARATOR

Participants randomized to the sham group, will place the TENS on the lateral side of the foot, the negative electrode on the top of the foot just above the small toe for conduction and the positive electrode on the bottom of below the smallest toe to avoid the tibial nerve and relevant cutaneous nerves. The location of conduction electrode was chosen since this location is proved to be away from bladder, pelvic, or major organ nerve acupuncture pathway. Participants will be instructed to raise up the intensity until the first and slight tingling sensation on the sole of the foot or toe. The stimulation will be used for 6 weeks, a total of 18 sessions, three times weekly for 30 minutes per session.

Device: Sham Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Active Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

For active group: Participants will useTENS to stimulate tibial nerve on the medial side of the foot for 6 weeks, a total of 18 sessions, three times weekly for 30 minutes per session. All TENS units will be programmed and locked by principal investigator to ensure fixed stimulation parameters are used among participants throughout the study intervention. The stimulation frequency will be set at 10 Hz with a pulse duration 200 μs. The stimulation is proved by flexion of the big toe (motor response) and/or tingling sensation of ipsilateral sole of foot (sensory response) by raising the current amplitude, mA, intensity. Increasing the intensity above sensory threshold is recommended but should not be painful

Transcutaneous Electrical Nerve Stimulation: Transcutaneous Tibial Nerve Stimulation

Sham Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

TENS on the lateral side of the foot, the negative electrode on the top of the foot just above the small toe for conduction and the positive electrode on the bottom of below the smallest toe to avoid the tibial nerve and relevant cutaneous nerves. Participants will be instructed to raise up the intensity until the first and slight tingling sensation on the sole of the foot or toe

Sham arm: Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

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

You may qualify if:

• Ambulatory (with or without assistive device)
• Aged ≥18 years old
• Able to understand spoken and written Arabic Language
• Self-reported with at least one bladder storage symptom such as urinary frequency urinary urgency, nocturia, with or without urge urinary incontinence
• Willing to give written informed consent
• Able to understand how to complete the study outcome measures

You may not qualify if:

• People with MS will be excluded if they have one or more of the following criteria at randomization:
• Indwelling urethral catheter
• Indwelling suprapubic catheter
• Bladder malignancy
• Diabetic mellitus
• Pregnant women or plan to be pregnant during the study intervention
• Recent pelvic related surgery \<1 year
• Pacemaker or other metallic internal devices
• Urinary tract infections (UTIs) during recruitment phase
• Unable to understand the instructions relating to operating the unit
• Having a bladder BOTOX-injection in the last 12-month

Sponsors & Collaborators

• Hawra Al-Dandan: lead

Study Sites (1)

King Fahd Hospital of the University

Khobar, Eastern Providence, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; 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

Study Officials

• Dr Hawra AL Dandan, PhD

  Imam Abdulrahman Bin Faisal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Hawra Al Dandan, PhD

CONTACT

+966555901977; hdandan@iau.edu.sa

Dr Saad Al Saadi, PhD

CONTACT

ssaadi@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and those who undertake data input and data analysis will be blind to group allocation to reduce the risk of performance bias. A principal investigator and co-investigator will insert data into SPSS so that the researchers can analyse data without having access to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior specialist

Model Details: Randomized, sham-controlled, double blind study with 1:1 allocation ratio.

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 2, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)