Leg Nerve Stimulation Feasible, May Help With Overactive Bladder in MS
Pilot trial supports further study of TTNS in patients with urinary frequency
Transcutaneous tibial nerve stimulation (TTNS), a procedure sending an electric current through the skin to nerves in the legs, is generally safe and feasible in people with overactive bladder due to multiple sclerosis (MS), according to a proof-of-concept study.
Though the study was not designed to test the efficacy of TTNS, data suggest that the intervention helped to ease bladder problems in patients.
“The current study demonstrates that TTNS is feasible, safe, and acceptable to [people with] MS. Changes of urinary symptoms scores between baseline and post-intervention suggested improvements in bladder storage symptoms and [quality of life] measures,” the researchers wrote.
The study, “Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis,” was published in Pilot and Feasibility Studies.
The vast majority of people with MS experience some form of bladder dysfunction, such as abnormally frequent or urgent urination. In addition to health problems, these symptoms can have a profound effect on a person’s quality of life.
More research needed into TTNS and overactive bladder in MS
TTNS is a nonsurgical intervention for bladder dysfunction that uses a device called a transcutaneous electrical nerve stimulation (TENS) unit to deliver electrical stimulation to specific nerves in the legs via two sticky pads, or electrodes.
The goal is to inhibit muscle contraction, relaxing the muscles around the bladder to lessen sensations of pressure or urgency.
While TTNS could help to ease bladder problems for people with MS, there has been little research into the effectiveness of this intervention, and scientists have called for well-designed studies to test it.
A team led by scientists at the University of Limerick, in Ireland, conducted a small proof-of-concept trial (NCT04528784) aiming to establish whether a large study evaluating the efficacy of TTNS in MS patients would be feasible.
“The primary aim of the current study is to assess the feasibility and acceptability of TTNS. The secondary aim is to explore changes in bladder storage symptoms and quality of life following treatment,” the researchers wrote.
Their trial enrolled 23 people with MS-related bladder symptoms. Each participant was given a TENS device and instructed in how to use it to deliver TTNS, which was given in 30-minute sessions three times per week for six weeks.
Of these 23 patients, three withdrew from the study or were lost to follow-up. The remaining 20 all completed the six-week study and administered all planned TTNS sessions, representing a 100% adherence.
“This study demonstrates the feasibility and acceptability of TTNS for bladder storage symptoms in [people with] MS using an accessible and affordable TENS unit. Our key progression criteria to continue to a pilot randomised controlled trial were achieved,” the researchers wrote.
Among these patients, six were male and 14 were female; 12 had relapsing-remitting MS while the other eight had progressive disease types. The most common bladder symptoms were frequent and/or urgent urination, and nocturia or waking up to urinate at night.
Side effects, reported by two patients, were red or dry skin at the site of TTNS application the first time the device was used, which cleared after a few days. No other safety-related events were reported.
In surveys, those who finished the trial generally reported that the TENS device was easy to use, and noted no issues with the frequency, duration, and timing of sessions.
“Participants reported high levels of satisfaction with the study protocol and high adherence was reported for completion of the 6 weeks intervention with no serious adverse events reported in the current study,” the researchers wrote.
During the study, patients kept diaries to track their bladder symptoms. Median daily urinations decreased from 10 before TTNS to eight after the intervention, while median daily urgency decreased from six to two. Episodes of nocturia did not change significantly.
Measures on standardized assessments of bladder symptom severity — namely, the Patient Perception of Intensity of Urgency Scale and the International Consultation of Incontinence Questionnaire-Overactive Bladder — generally trended toward improvement following the intervention.
Scores on the King’s Health Questionnaire, a health-related quality of life score for urinary symptoms, were also lower at six weeks, indicating a better quality of life.
“We did not seek to examine if participants experienced significant changes in urinary symptoms and quality of life from baseline to post-intervention due to our primary focus on exploring feasibility. However, changes in scores of urinary symptoms … suggest improvements of urinary frequency and urgency episodes post-intervention of TTNS,” the researchers wrote.
They noted this study is limited by the lack of a control group against which to make comparisons.
“These findings serve as a preliminary step to inform the development of an evidence-based future pilot randomised controlled trial (RCT) using standardised reporting of outcome measures,” the scientists wrote.
“We recommend following the treatment protocol, the electrical stimulation parameters, and the outcome measures applied in the current feasibility study for the implementation plan of the future pilot RCT,” they concluded.