An interventional study of Active Transcutaneous Electrical Nerve Stimulation (TENS) and Sham Transcutaneous Electrical Nerve Stimulation (TENS) in Overactive Bladder Syndrome, sponsored by Hawra Al-Dandan. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Hawra Al-Dandan · Not applicable, Interventional, and Treatment
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.
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) mainly affects young individuals. The mechanism responsible for MS initiates with the formation of acute inflammatory lesions categorized by breakdown of the blood-brain barrier (BBB) that causes scattered lesions in the brain and spinal cord , and it is the leading cause of autonomic dysfunction MS is increasingly a universal disease reported by joint project of the Multiple Sclerosis International Federation and the World Health Organization report . MS is more common in females than males with gender distribution ratio of 2.7:1. Likewise, the female: male ratio appears to be 3:1 in most developed countries.
The International Continence Society defines neurogenic lower urinary tract dysfunction (NLUTD) as lower urinary tract symptoms following neurological disease. The range and severity of neurogenic bladder symptoms depend on the location of the neurologic lesions, with more definite symptoms in people with MS associated with lesions at the pontine micturition centre (PMC) causing bladder storage symptoms and/ or the supra sacral lesions resulting in both bladder storage and voiding symptoms accompanied with an increased post-void residual. According to ICS classification of lower urinary tract symptoms terminology, bladder storage symptoms are a combination of urinary frequency, urinary urgency, nocturia, with or without urge urinary incontinence. Recent publication showed that bladder storage symptoms are the predominant symptoms among people with MS with an estimated pooled prevalence of frequency at 73.45% followed by urgency at 63.87%.
Several studies have reported the negative impacts of NLUTD on quality of life (QoL) among MS population including psychological distress, sleep disturbances, barriers to engaging in physical and social activities and disturbances of daily living. Previous studies showed the relationship between sleep disturbances and urinary symptoms. Also, sleep disturbance is associated with more severe urinary incontinence and overactive bladder symptoms. However, to date no studies have investigated the association of bladder storage symptoms and sleep disturbances among PwMS and bladder storage system and the possible impact of TTNS on quality of sleep among PwMS and bladder storage symptoms. Early diagnosis and proper management are of utmost importance in preserving good QoL among people with MS and urinary symptoms.
Management of bladder storage symptoms for neurogenic bladder population comprise pharmacological and non-pharmacological interventions. According to European Association of Urology (EAU), pharmacologic interventions include antimuscarinic which is considered as a first line intervention and Intradetrusor onabotulinumtoxin A (BOTOX) injections as a second-line treatment intervention. Non-pharmacologic interventions include patient education, life style modifications, behavioural interventions, pelvic floor muscle training (PFMT), and/ or neuromodulations. Tibial nerve stimulation (TNS) is a form of neuromodulation used to inhibit overactivity of detrusor muscle by using either a needle electrode (percutaneous tibial nerve stimulation) (PTNS), or adhesive pads (transcutaneous tibial nerve stimulation) (TTNS).
A number of small-scale studies demonstrate that tibial nerve stimulation (TTNS) may be a promising management approach for bladder storage symptoms in non-neurogenic and neurogenic bladder populations with the need of high quality studies to assess the effectiveness of this intervention. The exact mechanism by which TNS potentially treats bladder control is not yet fully understood.
To date no randomized controlled trials (RCT's) have been identified that explore the impact of TTNS on bladder storage symptoms, activity limitations and participation restrictions in people with MS. RCT's are required to provide a strong evidence-base for using TTNS among neurogenic bladder storage symptoms in MS. Recent publication of single-arm feasibility study showed that TTNS is feasible, safe, and acceptable as a treatment of bladder storage symptoms among PwMS. Therefore, there is a need to conduct RCTs using standardized reporting of outcome measures administering, widely available and affordable device, the transcutaneous electrical nerve stimulation (TENS) unit. In the current study the investigators chose the sham comparator to assess the efficacy of TTNS on bladder storage symptoms in MS population. Sham intervention enable to reduce uncertainty regarding the causal relationship between an intervention and outcome, also it is suitable in the beginning phases of efficacy-exploratory research when it is still unknown whether the given treatment has any effect.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 72 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →This is the only study on the registry with Hawra Al-Dandan as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
People with MS will be excluded if they have one or more of the following criteria at randomization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol)
Patient-completed questionnaire to measure the impact of urinary symptoms in quality of life. Overall scores ranges from19-76 with greater values indicating increased impact on quality of life. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient
Time frame: 2 months
Pittsburgh Sleep Quality Index (PSQI)-item 6
The item scored on a 0-3-point scale, where 0 = very good sleep quality and 3 = very bad sleep quality
Time frame: 2 months
Global Perceived Effect (GPE) Scale
Participant's perception of change post intervention will be assessed using a numeric scale from -5 to 5 with higher values indicating a better outcome.
Time frame: 2 months
Plan to share: No
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Started Mar 2024 (actual). Primary completion is estimated for Nov 2026, 32 months after the start.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 32 months is above that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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