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Completed

NCT Number: NCT07070063

Virtual Reality for Urinary Incontinence in Women

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Disorder Pelvic Floor Disorders Pregnancy Complications Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Wroclaw, Lower Silesian Voivodeship, 50-233, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immersive Virtual Reality Therapy

Device

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.

Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

Device

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.

Primary outcomes

  1. Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score

    Time frame: 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 outcomes

  1. Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score at 2-Week Post-Intervention Follow-Up

    Time frame: 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.

  2. Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Subscale Scores

    Time frame: 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.

  3. Change from Baseline in the Incontinence Impact Questionnaire-Short Form (IIQ-7) Total Score

    Time frame: 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.

  4. Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-Short Form (PISQ-12) Total Score

    Time frame: 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.

  5. Change from Baseline in the King's Health Questionnaire (KHQ) Domain Scores

    Time frame: 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.

  6. Change from Baseline in the Perceived Stress Scale (PSS-10)

    Time frame: 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.

  7. Change from Baseline in the Rosenberg Self-Esteem Scale (SES) Total Score

    Time frame: 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.

  8. Change from Baseline in Pelvic Floor Muscle EMG Activity at Rest and During Maximal Voluntary Contraction

    Time frame: 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.

  9. Change from Baseline in Bladder Diary Micturition Volume Parameters

    Time frame: 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.

  10. Change from Baseline in Micturition Frequency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Collaborators

  • Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław
  • Jan Dlugosz University in Czestochowa
  • Wroclaw Medical University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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