Effect of a Peripheral Neuromodulation Protocol Combined with the Application of Therapeutic Exercise in Patients Diagnosed with Urinary Incontinence-A Study Protocol for a Randomized Controlled Trial.

Abstract

Introduction: Overactive bladder (OAB) and urinary incontinence (UI) are prevalent, particularly in older adults, and affect quality of life. OAB involves urgency, frequency, nocturia, and urgency incontinence, often linked to involuntary detrusor contractions. Treatment guidelines recommend a stepwise approach, starting with pelvic floor muscle training (PFMT), followed by pharmacological or minimally invasive therapies, such as neuromodulation. However, the combined effects of PFMT and neuromodulation have not been well established. This study aimed to evaluate the impact of combining pelvic floor exercises with neuromodulation versus PFMT with sham neuromodulation or standard physiotherapy after a 12-week intervention in individuals with OAB and UI. Methods/Materials: A double-blind, randomized controlled trial was designed with three groups: PFMT + neuromodulation, PFMT + sham, and conventional physiotherapy (control) in a 1:1:1 ratio. This study followed the CONSORT guidelines and was registered at ClinicalTrials.gov (NCT06783374). The sample size was calculated using GPower^® software, assuming a Cohen's effect size of 1.04, a power of 0.80, an alpha of 0.05, and a 15% dropout rate, totaling 63 participants (21 per group). Participants attended 24 sessions over 12 weeks (2 sessions per week). The interventions were based on previously validated protocols. Outcomes: The primary outcomes included health-related quality of life, pelvic floor muscle function, pain, adherence, and general health. The secondary outcomes included Incontinence Quality of Life questionnaire, 3-day bladder diary, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, kinesiophobia, and electromyographic data.