Virtual Reality for Urinary Incontinence in Women

NCT ID: NCT07070063

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-06-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR Group

VR-Supported Pelvic Floor Training

Group Type: EXPERIMENTAL

Virtual Reality Therapy

Intervention Type: DEVICE

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

Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

Intervention Type: DEVICE

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.

Control Group

Conventional Pelvic Floor Training

Group Type: ACTIVE_COMPARATOR

Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women aged 50-80 years, who are at least 12 months post-menopausal,
• Diagnosed with urinary incontinence of grade I or IIa according to the ICS classification,
• No contraindications to participation (e.g., acute urinary tract infections, severe neurological disorders),
• Provision of written informed consent to participate in the research experiment.

Exclusion Criteria

• Urinary incontinence of grade III or higher,
• Presence of significant neurological conditions affecting bladder control,
• Participation in other therapeutic interventions that could interfere with study outcomes,
• Pregnancy,
• Refusal or inability to provide informed consent.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław

UNKNOWN

Sponsor Role: collaborator

Jan Dlugosz University in Czestochowa

OTHER

Sponsor Role: collaborator

Wroclaw Medical University

OTHER

Sponsor Role: collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Joanna Szczepańska-Gieracha

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriela Kołodyńska, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw University of Health and Sport Sciences, Poland

Joanna Szczepańska-Gieracha, Professor

Role: PRINCIPAL_INVESTIGATOR

Wroclaw University of Health and Sport Sciences, Poland

Maciej Zalewski, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University (Poland)

Waldemar Andrzejewski, Professor

Role: PRINCIPAL_INVESTIGATOR

Wroclaw University of Health and Sport Sciences, Poland

Locations

Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Gabriela Kołodyńska, PhD

Role: CONTACT

gabriela.kolodynska@awf.wroc.pl

608134579 ext. +48

Facility Contacts

Gabriela Kołodyńska, PhD

Role: primary

gabriela.kolodynska@awf.wroc.pl

608134579 ext. +48

Other Identifiers

49/2025

Identifier Type: -

Identifier Source: org_study_id