Effectiveness of electrical stimulation with conservative treatment for lower urinary tract symptoms in Parkinson's disease: A three-armed randomized controlled trial protocol

Abstract

Background: Despite the high prevalence of lower urinary tract symptoms (LUTS) in patients with Parkinson's disease (PD)-ranging from 27 % to 85 % including symptoms such as urinary urgency,- incontinence, frequency, and nocturia-evidence-based treatment options remain limited. Conservative treatments, such as bladder training, pelvic floor muscle exercises (PFME) with biofeedback and electrical stimulation, have been shown safe and effective in the general population, with minimal side effects. However, their efficacy specifically in PD patients remains unclear. Therefore this study aims to evaluate the effect of electrical stimulation with conservative treatment for LUTS in PD patients.

Methods and analysis: This randomized controlled trial includes three study arms. All three groups will receive conservative treatment in combination with different electrical stimulation parameters, small- and broad pulse duration and sham electrical stimulation. In total 150 PD patients with self-reported LUTS who are able to attend a pelvic physical therapy practice independently and complete online questionnaires will be enrolled. The primary outcome is the difference in international prostate symptom score (IPSS), with a range of 0-35.A minimal important difference of 4.2 between baseline and 12 weeks of treatment will be statistical significant (p˂0.05). Secondary outcome include questionnaires evaluating bladder dysfunction, burden, and quality of life and will be collected at baseline, 12 weeks and 24 weeks and at one year. Additionally pelvic floor muscle function will be assed at baseline and after 12 weeks.All participants receive eight sessions along with their assigned electrical stimulation treatment and conservative treatment.

Fig. 1

Study design flow diagram LUTS: lower urinary tract symptoms; IPSS: international Prostate symptom score; ICIQ-UI SF: International Consultation on Incontinence Questionnaire urinary incontinence short form; ICIQ-LUTS-qol: International Consultation on Incontinence Questionnaire Lower urinary tract symptoms quality of live; ICIQ-OAB: International Consultation on Incontinence Questionnaire Overactive Bladder; BD: bladder diary; A-PPT: Assessment Pelvic Physical Therapist; ES: electrical stimulation; PFME: pelvic floor muscle exercise.