Pelvic Floor Disorder, Urinary Incontinence
Conditions
Keywords
Virtual Reality, Rehabilitation, Pelvic Floor Muscle Training, Urinary incontinence, Women's health
Brief summary
This assessor-blinded, non-randomized, parallel-group controlled study evaluated whether adding immersive virtual reality to pelvic floor muscle electrostimulation with electromyographic biofeedback improved incontinence-related quality of life in postmenopausal women with urinary incontinence. Participants received electrostimulation with EMG biofeedback alone or the same intervention preceded by a 20-minute immersive VR session.
Detailed description
Urinary incontinence is a common condition among women and may adversely affect quality of life, psychological well-being, and social functioning. Conservative management may include pelvic floor muscle training, neuromuscular electrical stimulation, and electromyographic biofeedback. Virtual reality may be used as an adjunctive intervention intended to promote relaxation and engagement during rehabilitation; however, evidence regarding its use in women with urinary incontinence remains limited. This study investigated immersive virtual reality as an adjunct to pelvic floor electrostimulation and electromyographic biofeedback in women with urinary incontinence. The VR intervention was intended to support relaxation and engagement during rehabilitation. It was delivered as a separate session immediately before electrostimulation and EMG biofeedback and included a gradually evolving garden environment, mandala-painting tasks, and guided breathing exercises. The VR system was not technically integrated with the EMG biofeedback device and did not provide real-time visualization of pelvic floor muscle activity.
Interventions
Eight approximately 20-minute immersive virtual reality sessions were administered over a 2-week period, with four sessions per week. The intervention was delivered using the VRTierOne system (Stolgraf®) immediately before pelvic floor muscle electrostimulation and EMG biofeedback. The virtual environment consisted of a gradually evolving therapeutic garden and included mandala-painting tasks and guided breathing exercises intended to support relaxation and engagement in the rehabilitation process. The VR system was not technically integrated with the EMG biofeedback device and did not provide real-time visualization of pelvic floor muscle activity.
DEVICEPelvic Floor Muscle Electrostimulation with EMG Biofeedback
Eight sessions of pelvic floor muscle electrostimulation followed by EMG biofeedback were delivered over 2 weeks (four sessions/week) using the NeuroTrac® MyoPlus 4 Pro and an individually assigned intravaginal probe. Stimulation consisted of symmetrical biphasic rectangular pulses at 50 Hz and 250 μs, with 5 seconds of stimulation, 10 seconds of rest, and 1-second ramp-up and ramp-down periods. Each electrostimulation session lasted 20 minutes. Intensity was increased to the highest comfortably tolerated level producing a visible or palpable pelvic floor muscle contraction. This was followed by approximately 5 minutes of EMG biofeedback training with real-time visualization of muscle activity.
Sponsors
Wroclaw University of Health and Sport Sciences
Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław
Jan Dlugosz University in Czestochowa
Wroclaw Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants were assigned to the intervention groups based on the organizational and technical availability of the virtual reality system during the recruitment period. No random sequence generation or allocation concealment was used.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 50-80 years, who are at least 12 months post-menopausal, * Diagnosed with urinary incontinence of grade I or II according to the Stamey 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score | Baseline and immediately after the 2-week intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score at 2-Week Post-Intervention Follow-Up | Baseline and 2 weeks after completion of the intervention | 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. |
| Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Subscale Scores | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention. | The I-QOL comprises three subscales: avoidance and limiting behavior, psychosocial impact, and social embarrassment. Each subscale score is transformed to a 0-100 scale, with higher scores indicating better incontinence-related quality of life. Changes in the three subscale scores are evaluated separately. |
| Change from Baseline in the Incontinence Impact Questionnaire-Short Form (IIQ-7) Total Score | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention | 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. |
| Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-Short Form (PISQ-12) Total Score | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention | The PISQ-12 is a 12-item questionnaire assessing sexual function in sexually active women with urinary incontinence and/or pelvic organ prolapse. Total scores range from 0 to 48, with higher scores indicating better sexual function. |
| Change from Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention | 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. Domain scores were evaluated separately. |
| Change from Baseline in the Perceived Stress Scale (PSS-10) | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention | The PSS-10 is a 10-item questionnaire assessing the degree to which situations in an individual's life are perceived as stressful. Items are rated on a 5-point scale from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. |
| Change from Baseline in the Rosenberg Self-Esteem Scale (SES) Total Score | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention | The SES is a 10-item scale measuring global self-esteem. The Polish adaptation maintains the original structure and uses a 4-point Likert scale. Scores range from 10 to 40, with higher values reflecting higher self-esteem. |
| Change from Baseline in Pelvic Floor Muscle EMG Activity at Rest and During Maximal Voluntary Contraction | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention. | Pelvic floor muscle activity is assessed using an intravaginal EMG probe and expressed as root mean square amplitude in microvolts (µV). EMG activity at rest and during maximal voluntary contraction is evaluated separately. |
| Change from Baseline in Bladder Diary Micturition Volume Parameters | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention. | Mean, minimum, and maximum voided volumes are derived from bladder diaries and expressed in milliliters. Changes in the three volume parameters are evaluated separately. |
| Change from Baseline in Micturition Frequency | Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention. | Micturition frequency is derived from bladder diaries and expressed as the number of micturitions per 24 hours. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORGabriela Kołodyńska, PhD
Wroclaw University of Health and Sport Sciences, Poland
PRINCIPAL_INVESTIGATORJoanna Szczepańska-Gieracha, Professor
Wroclaw University of Health and Sport Sciences, Poland
PRINCIPAL_INVESTIGATORMaciej Zalewski, PhD
Wroclaw Medical University
PRINCIPAL_INVESTIGATORWaldemar Andrzejewski, Professor
Wroclaw University of Health and Sport Sciences, Poland
Outcome results
None listed