Evaluation of Pelvic Floor Muscle Training with and without the Aniball INCO Vaginal Device for Treating Stress Urinary Incontinence in Women Aged 18 to 80

What this Trial Is About

Researchers are evaluating the clinical effectiveness of pelvic floor muscle training PFMT in women with stress urinary incontinence. The study compares two conservative therapy methods home exercise training using a medical vaginal device called Aniball INCO versus standard pelvic floor muscle training exercises without the device. This research aims to improve treatment options for women experiencing this condition. Participants are randomly assigned to one of two groups. The first group performs pelvic floor muscle training using the Aniball INCO vaginal device following education by a urogynecologist. The second group receives pelvic floor muscle training without the device, guided by a certified physiotherapist trained in pelvic floor disorders. Both groups follow their respective training programs over several months. During the study, participants complete questionnaires like the International Consultation on Incontinence Questionnaire ICIQ-SF at the start, after 8 weeks, and after 4 months. Objective urodynamic tests and measurements of urine leakage are conducted at baseline and after 4 months. Researchers monitor clinical severity changes and the effectiveness of the treatments, with the total participation lasting around 4 months. Safety and adherence are also observed throughout the study.

Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence