Impact of TTNS on Bladder Symptoms Among People With MS, A RCT
Recruiting · NCT06341673 · Interventional (participants receive a specific treatment) · Lead sponsor: Hawra Al-Dandan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- King Fahd Hospital of the University - Khobar, Eastern Providence, Saudi Arabia