Transcutaneous tibial nerve stimulation for the treatment of bladder dysfunction in patients with neurological disorders: A randomized, sham-controlled, double-blind clinical study.

Descrizione riassuntiva dello studio

Bladder dysfunction is common in patients with a neurological disorder (so-called neurogenic bladder dysfunction) and can limit quality of life as well as lead to long-term kidney damage. Treatments with medications often do not lead to sufficient improvement of symptoms and/or have bothersome side effects. Tibial nerve stimulation therapy (nerve located behind the inner ankle) offers a potentially well-tolerated treatment method. A self-adhesive skin electrode is placed behind the inner ankle and an electrode on the arch of the foot. A low-voltage stimulator (9 volts) stimulates the tibial nerve for 30 minutes. The electrical impulses are transmitted via the tibial nerve to the spinal cord, which is important for bladder control, and lead, with repeated application, to an improvement in bladder symptoms in many patients. Although the exact mechanisms are not fully understood, the repeated performance of this type of electrical stimulation therapy is particularly important for the success of the treatment. Experience shows that a noticeable improvement is only observed after approximately 6 stimulations, so treatment cycles with 12 stimulations have become established. This type of electrical stimulation therapy has proven effective in patients without neurological disorders and offers an excellent and almost side-effect-free alternative to treatments such as Botox injections into the bladder muscle or surgeries on the bladder. The aim of the study is to investigate the benefits of tibial nerve stimulation therapy in patients with bladder dysfunction due to neurological disorders.

(BASEC)

Intervento studiato

Patients who meet the inclusion criteria and agree to participate in the study will be randomly assigned (randomization) to the treatment or sham treatment group. Patients in both groups will be connected for 30 minutes to a low-voltage stimulator (9 volts) ELPHA II 3000 (Danmeter S/A) via skin electrodes on the foot, twice a week for 6 weeks (a total of 12 sessions). The device settings will be made by a medical professional, who will be the only one to know the group allocation of the participants. Neither the study participant nor the medical professionals who will assess the study results will know in which group the participant is. On the days between the stimulation sessions, participants will be asked to keep a bladder diary, i.e., to document the times and amounts of fluid intake and urine output, as well as involuntary urine losses and pad usage. At every second session, patients will be asked to fill out a questionnaire on urinary incontinence, bladder symptoms and bladder perception, sexual and bowel function, and quality of life. After the last TTNS session (total of 12 TTNS sessions, 2 per week, i.e., 6 weeks in total), a clinical follow-up will take place within one week with a urine test, bladder diary, questionnaires on urinary incontinence, bladder symptoms and bladder perception, sexual and bowel function, quality of life, as well as urodynamics and neurophysiological follow-up.

(BASEC)

Malattie studiate

Patients in whom bladder dysfunction due to a neurological disorder (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury, etc.) has been diagnosed through bladder pressure measurement (urodynamics), accompanied by strong urgency, urine loss, and/or incomplete emptying of the bladder.

(BASEC)

Sponsor

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