NCT07070063

Virtual Reality for Urinary Incontinence in Women

Use of Virtual Reality in the Treatment of Various Types of Urinary Incontinence in Women

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wroclaw University of Health and Sport Sciences · Academic / Other
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of using virtual reality to support pelvic floor muscle training in women with urinary incontinence. The intervention aims to enhance patients' motivation, awareness, and exercise accuracy through real-time muscle visualization and immersive interaction. The project seeks to determine whether virtual reality-assisted therapy improves clinical outcomes compared to conventional approaches.

Detailed description

Urinary incontinence (UI) is a common condition among women, negatively impacting quality of life, mental health, and social functioning. Although pelvic floor muscle training (PFMT) is an effective treatment, its success depends on proper technique and patient engagement-both of which are often insufficient due to limited education and challenges in exercise monitoring. Virtual reality (VR) offers an innovative approach to support rehabilitation by providing real-time biofeedback, enhancing awareness of pelvic floor muscle function, and increasing motivation through immersive, interactive environments. Prior research suggests that VR can improve concentration, reduce therapy-related anxiety, and encourage active participation. This study aims to evaluate the effectiveness of a VR-based system integrated with biofeedback in supporting PFMT for women with UI. Through real-time visualization of pelvic floor activity, the intervention may improve muscle control, exercise adherence, and clinical outcomes. The project responds to the global trend of using digital tools in rehabilitation and addresses a gap in the literature concerning VR applications in urogynecology. While VR has shown promise in neurological and orthopedic rehabilitation, its potential in UI management remains underexplored. This trial seeks to generate evidence for its effectiveness and practical use in the treatment of urinary incontinence.

Conditions

• Urinary Incontinence
• Pelvic Floor Disorder

Interventions

Type	Name	Description
DEVICE	Virtual Reality Therapy	Eight sessions of virtual reality therapy will be administered over a two-week period (four sessions per week, each lasting 20 minutes). The intervention will be delivered using the VRTierOne device (Stolgraf®), which employs a head-mounted display to create a fully immersive environment. Through the integration of visual, auditory, and kinesthetic stimuli, the therapy provides a multi-sensory experience that can have calming and mood-enhancing effects, as well as support psychological engagement and motivation in the rehabilitation process. The virtual environment-designed as a therapeutic garden-is rich in symbols and metaphors derived from Ericksonian psychotherapy. The central element of this environment is the Garden of Revival, a metaphor for the patient's health. Once vibrant and full of life, the garden is now neglected and requires care and effort to be restored. Throughout the therapeutic process, the patient is guided by a symbolic narrative reflecting their individual
DEVICE	Pelvic Floor Muscle Electrostimulation with EMG Biofeedback	Eight sessions of pelvic floor muscle electrostimulation combined with EMG biofeedback will be provided over a two-week period (four sessions per week). The intervention will be delivered using a specialized EMG-Biofeedback electrostimulation device equipped with a screen for real-time signal visualization. Vaginal electrodes will be used to ensure precise stimulation and accurate detection of pelvic floor muscle activity. During each 30-minute session, patients will receive symmetrical biphasic rectangular electrical impulses at a frequency of 50 Hz, with a 5-second stimulation phase followed by a 10-second rest period. The intensity of the stimulation will be individually adjusted to ensure both safety and comfort. The integrated biofeedback system will allow participants to observe their muscle activation patterns on the screen, enhancing their awareness and control of pelvic floor function and supporting the learning of correct activation during voluntary contractions.

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-09-30
• Completion: 2027-06-15
• First posted: 2025-07-17
• Last updated: 2025-07-24

Locations

1 site across 1 country: Poland