Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341673
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-06
Brief Title:
Impact of TTNS on Bladder Symptoms Among People With MS A RCT
Sponsor:
Hawra Al-Dandan
Organization:
Imam Abdulrahman Bin Faisal University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 7345 followed by urgency at 6387 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 MSMethods 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 Participants 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 005
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
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 271 Likewise the female male ratio appears to be 31 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 7345 followed by urgency at 6387
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 RCTs have been identified that explore the impact of TTNS on bladder storage symptoms activity limitations and participation restrictions in people with MS RCTs 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
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 7345 followed by urgency at 6387
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 RCTs have been identified that explore the impact of TTNS on bladder storage symptoms activity limitations and participation restrictions in people with MS RCTs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None