Urinary IncontinenceNCT07070063
Virtual Reality for Urinary Incontinence in Women
A study testing Immersive Virtual Reality Therapy and Pelvic Floor Muscle Electrostimulation with EMG Biofeedback in people with Urinary Incontinence and Pelvic Floor Disorder, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Urinary Incontinence, Pelvic Floor Disorder
- What is being tested?
- Immersive Virtual Reality Therapy and Pelvic Floor Muscle Electrostimulation with EMG Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jul 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław
Wroclaw, Lower Silesian Voivodeship, 50-233
About this study
Official title: Use of Virtual Reality in the Treatment of Various Types of 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.
Read the 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.
- Conditions
- Urinary Incontinence, Pelvic Floor Disorder
- Being tested
- Immersive Virtual Reality Therapy, Pelvic Floor Muscle Electrostimulation with EMG Biofeedback
- Keywords
- Virtual Reality, Rehabilitation, Pelvic Floor Muscle Training, Urinary incontinence, Women's health
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality TherapyDevice
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 BiofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VR + ES Group | Experimental | Participants received immersive virtual reality immediately before pelvic floor muscle electrostimulation and EMG biofeedback. Receives: Device: Immersive Virtual Reality Therapy; Device: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback |
| ES Group | Active comparator | Participants received pelvic floor muscle electrostimulation followed by EMG biofeedback without virtual reality. Receives: Device: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score
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.
Measured: Baseline and immediately after the 2-week intervention
Secondary outcomes (10)
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score at 2-Week Post-Intervention Follow-Up
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.
Measured: Baseline and 2 weeks after completion of the intervention
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Subscale Scores
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.
Change from Baseline in the Incontinence Impact Questionnaire-Short Form (IIQ-7) Total Score
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention
Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-Short Form (PISQ-12) Total Score
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention
Change from Baseline in the King's Health Questionnaire (KHQ) Domain Scores
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention
Change from Baseline in the Perceived Stress Scale (PSS-10)
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention
Change from Baseline in the Rosenberg Self-Esteem Scale (SES) Total Score
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention
Change from Baseline in Pelvic Floor Muscle EMG Activity at Rest and During Maximal Voluntary Contraction
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.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.
Change from Baseline in Bladder Diary Micturition Volume Parameters
Mean, minimum, and maximum voided volumes are derived from bladder diaries and expressed in milliliters. Changes in the three volume parameters are evaluated separately.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.
Change from Baseline in Micturition Frequency
Micturition frequency is derived from bladder diaries and expressed as the number of micturitions per 24 hours.
Measured: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 Jul 2025
- Primary completion30 Nov 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Joanna Szczepańska-Gieracha, Wroclaw University of Health and Sport Sciences
- Investigators
- Gabriela Kołodyńska, PhD, Principal investigator, Wroclaw University of Health and Sport Sciences, PolandJoanna Szczepańska-Gieracha, Professor, Principal investigator, Wroclaw University of Health and Sport Sciences, PolandMaciej Zalewski, PhD, Principal investigator, Wroclaw Medical UniversityWaldemar Andrzejewski, Professor, Principal investigator, Wroclaw University of Health and Sport Sciences, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070063
- Sponsor's protocol ID
- 49/2025
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in the Treatment of Various Types of Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT07070063
- Acronym / sponsor ID
- 49/2025
- Conditions
- Urinary Incontinence, Pelvic Floor Disorder
- Keywords
- Virtual Reality, Rehabilitation, Pelvic Floor Muscle Training, Urinary incontinence, Women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or 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
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR + ES Group | Experimental | Device: Immersive Virtual Reality Therapy, Device: Pelvic Floor Muscle Electrostimulation with EMG BiofeedbackParticipants received immersive virtual reality immediately before pelvic floor muscle electrostimulation and EMG biofeedback. |
| ES Group | Active comparator | Device: Pelvic Floor Muscle Electrostimulation with EMG BiofeedbackParticipants received pelvic floor muscle electrostimulation followed by EMG biofeedback without virtual reality. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality TherapyEight 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. | Device | VR + ES Group |
| Pelvic Floor Muscle Electrostimulation with EMG BiofeedbackEight 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. | Device | ES Group, VR + ES Group |
Primary outcome
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.
10 secondary outcomes
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
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.
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
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
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
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
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
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.
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.
Change from Baseline in Micturition Frequency
Time frame: Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Kołodyńska, PhD principal investigator
Wroclaw University of Health and Sport Sciences, Poland
Joanna Szczepańska-Gieracha, Professor principal investigator
Wroclaw University of Health and Sport Sciences, Poland
Maciej Zalewski, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Therapy and Pelvic Floor Muscle Electrostimulation with EMG Biofeedback in people with Urinary Incontinence and Pelvic Floor Disorder, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score (time frame: Baseline and immediately after the 2-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.