Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: randomized controlled trial with economic evaluation

• Grant number: 24/05325-0
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: August 01, 2025
• End date: April 30, 2028
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Patricia Driusso
• Grantee: Ingrid da Costa Vilela
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil

Abstract

Introduction: Pelvic floor muscle training exercises (PFMT) and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, the effect of PFMT associated with intravaginal NMES has not yet been described to evaluate the cost-effectiveness and cost-utility of the treatment. Objectives: To evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life and to evaluate the cost-effectiveness and cost-utility in women with SUI. Methods: Randomized controlled study with economic evaluation. The inclusion criteria are a woman (biological), aged e 18 years, who knows how to read and write in Portuguese, who is available to provide face-to-face care in São Carlos, with symptoms of SUI in the last month. Participants will be excluded: those who will not have sexual activity with vaginal penetration, pregnant women, in the postpartum period for less than 6 months, who have a vaginal or urinary infection, neurological disease, cancer in the abdominal or pelvic region, metal implant or hip/knee prosthesis, who have already undergone treatment or surgery for UI, with the presence of pain or discomfort that makes intervention with NMES impossible or with an inability to perform PFM contraction. Participants will undergo assessment and physiotherapeutic intervention: anamnesis, assessment of the pelvic floor muscles, global effect perception scale, questionnaires (Short-Form 6 Dimensions-Brazil (SF-6D), King's Health Questionnaire (KHQ) and King's Health Questionnaire for Scoring Algorithm (KHQ QALY), healthcare costs) and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), GI 1 (intervention group 1, PFMT) and GI 2 (intervention group 2, intravaginal NMES + PFM contraction). Statistical analysis will be performed using statistical software and by intention to treat. A significance level of 5% will be adopted and multivariate mixed effects analysis will be used to compare the results. In addition, the incremental cost-effectiveness and incremental cost-utility ratios will be used.