Virtual Reality for Urinary Incontinence in Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-80
SponsorWroclaw University of Health and Sport Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Therapy
DeviceEight 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
DeviceEight 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VR GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) at 2 weeks
The I-QOL is a 22-item instrument designed to assess the impact of urinary incontinence on quality of life in women. It covers three domains: avoidance and limiting behaviors, psychosocial impacts, and social embarrassment. Items are rated on a 5-point Likert scale (1 = extremely to 5 = not at all). Scores are transformed into a scale ranging from 0 to 100, with higher scores indicating better quality of life.
Time frame
From enrollment to the end of treatment at 2 weeks.Secondary outcomes
1
Change from Baseline in the Incontinence Impact Questionnaire - Short Form (IIQ-7) at 2 weeks
The IIQ-7 is a 7-item instrument that assesses the impact of urinary incontinence on various aspects of daily life, including physical activity, social relationships, emotional well-being, and travel. Each item is scored from 0 (not at all) to 3 (greatly), and total scores are standardized to a 0-100 scale. Higher scores indicate greater negative impact on quality of life.
Time frame
From enrollment to the end of treatment at 2 weeks.2
Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) at 2 weeks
The PISQ-IR evaluates sexual function in women with urinary incontinence or pelvic organ prolapse. It includes separate domains for sexually active and inactive women, assessing aspects such as desire, satisfaction, and emotional impact. Higher scores in each domain indicate better sexual function and less impact of symptoms.
Time frame
From enrollment to the end of treatment at 2 weeks.3
Change from Baseline in the Gaudenz Questionnaire for the Assessment of Urinary Incontinence Severity at 2 weeks
The Gaudenz Questionnaire assesses urinary incontinence severity through structured questions on leakage frequency, volume, triggers, and pad usage. It provides a detailed clinical profile of symptom severity, though not a single summary score.
Time frame
From enrollment to the end of treatment at 2 weeks.4
Change from Baseline in the King's Health Questionnaire (KHQ) at 2 weeks
The KHQ is a validated quality-of-life tool for individuals with urinary incontinence. It includes multiple domains such as general health perception, role limitations, physical limitations, social relationships, emotions, and sleep/energy. Each domain is scored on a 0-100 scale, with higher scores indicating greater impairment.
Time frame
From enrollment to the end of treatment at 2 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wroclaw University of Health and Sport Sciences
Lead sponsor
Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław
Collaborator
Jan Dlugosz University in Czestochowa
Collaborator
Wroclaw Medical University
Collaborator
Source ClinicalTrials.gov