Overactive Bladder SyndromeNCT06341673
Impact of TTNS on Bladder Symptoms Among People With MS, A RCT
A study testing Active Transcutaneous Electrical Nerve Stimulation (TENS) in people with Overactive Bladder Syndrome, run by Hawra Al-Dandan at 1 site in Saudi Arabia.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Active Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Mar 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Saad Al Saadi, PhD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahd Hospital of the University
Khobar, Eastern Providence
Dr Hawra Al Dandan, PhD, +966555901977, hdandan@iau.edu.sa
Dr Saad Al Saadi, PhD, +966552519515, ssaadi@iau.edu.sa
About this study
Official title: Impact of Transcutaneous Tibial Nerve Stimulation on Bladder Storage Symptoms and Quality of Life in People With Multiple Sclerosis- A Randomised Controlled Trial"
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.
Read the detailed description
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.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Active Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Multiple Sclerosis, Overactive bladder, Bladder storage symptoms, Incontinence, Tibial nerve stimulation, Stimulation
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Mar 2024
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham-controlled, double blind study with 1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawra Al-Dandan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hawra Al-Dandan, Imam Abdulrahman Bin Faisal University
- Investigators
- Dr Hawra AL Dandan, PhD, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341673
- Sponsor's protocol ID
- IRB-2023-O3-442
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcutaneous Tibial Nerve Stimulation on Bladder Storage Symptoms and Quality of Life in People With Multiple Sclerosis- A Randomised Controlled Trial"
- ClinicalTrials.gov ID
- NCT06341673
- Acronym / sponsor ID
- IRB-2023-O3-442
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Multiple Sclerosis, Overactive bladder, Bladder storage symptoms, Incontinence, Tibial nerve stimulation, Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hawra Al-DandanUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Apr 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, sham-controlled, double blind study with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation: Transcutaneous Tibial Nerve Stimulation | Active comparator | Device: Active Transcutaneous Electrical Nerve Stimulation (TENS)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. |
| Sham arm: Transcutaneous Electrical Nerve Stimulation | Sham comparator | Device: Sham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Active 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 | Device | Transcutaneous Electrical Nerve Stimulation: Transcutaneous Tibial Nerve Stimulation |
| Sham Transcutaneous Electrical Nerve Stimulation (TENS)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 | Device | Sham arm: Transcutaneous Electrical Nerve Stimulation |
Primary outcome
The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB)
Time frame: 2 months
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.
3- day Bladder diary
Time frame: 2 months
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.
Urinary sensation scale.
Time frame: 2 months
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.
3 secondary outcomes
The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol)
Time frame: 2 months
Pittsburgh Sleep Quality Index (PSQI)-item 6
Time frame: 2 months
Global Perceived Effect (GPE) Scale
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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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.
Dr Saad Al Saadi, PhD contact
Dr Hawra AL Dandan, PhD principal investigator
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Electrical Nerve Stimulation (TENS) in people with Overactive Bladder Syndrome, run by Hawra Al-Dandan at 1 site in Saudi Arabia.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hawra Al Dandan, PhD (+966555901977, hdandan@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026.