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This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .
This study is significant as it explores the potential of VR technology to improve the effectiveness of pelvic floor rehabilitation, addressing a critical gap in postpartum care.
Postpartum SUI is a prevalent condition affecting approximately 30-40% of women after childbirth, significantly impairing their quality of life and psychological well-being. Traditional pelvic floor muscle training (PFMT) remains the first-line of treatment, yet adherence and engagement are often suboptimal due to monotony and lack of motivation. VR assisted rehabilitation presents an innovative approach to enhance patient participation by providing immersive, interactive, and engaging therapy sessions.
Furthermore, this research contributes to the growing body of evidence on digital health interventions in women's health, aligning with global trends toward tele-rehabilitation and personalized medicine By evaluating the efficacy and feasibility of VR in postpartum SUI rehabilitation, this study may inform clinical guidelines and encourage healthcare providers to adopt innovative technologies for better patient outcomes.
Lastly, improving postpartum SUI treatment has broader socioeconomic implications, as untreated SUI leads to increased healthcare costs and reduced work productivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment | Experimental | Participants in this group will practice pelvic floor muscle rehabilitation supported by an immersive virtual reality system designed to enhance engagement and real-time biofeedback during exercise sessions in addition to medical treatment for SUI. The Intervention will last for 8 weeks, with training sessions conducted three times per week under physiotherapist supervision. |
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| Medical treatment | Other | Participants in this group will receive medical treatment for SUI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle rehabilitation supported by an immersive VR | Other | The VR intervention, known as the VR Personality Project, will be delivered using an adjustable virtual reality headset equipped with integrated audio through the head-mounted display. Each participant will use lightweight, wireless Bluetooth controllers to engage and interact with the virtual environment. The Intervention will last for 8 weeks, with training sessions conducted three times per week under physiotherapist supervision. All participants will undergo baseline assessment prior to randomization, followed by a post-intervention assessment at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pelvic floor muscle strength | Assessment of pelvic floor muscle strength through Kegel perineometer provides a non-invasive and reproducible method to evaluate pelvic floor muscle (PFM) function in women, particularly in cases such as stress urinary incontinence and postpartum recovery. Normal PFM strength typically ranges between 30-60 mmHg (approximately 20-40 cmHâ‚‚O), with variations depending on age and parity. Readings below 15 mmHg indicate weakness and possible dysfunction, whereas values above 40 mmHg reflect good to strong muscle strength. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | The questionnaire comprises 4 items (6 total questions, including (demographics) assessing UI frequency, leakage volume, QoL impact, and perceived cause. The total score (0-21) sums items 3-5, with higher scores indicating greater severity: slight (1-5), moderate (6-12), severe (13-18), and very severe (19-21The unscored self-diagnostic item (Question 6) aids clinical discussion but lacks etiological specificity). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa Adel Khamees, B.Sc | Contact | +20 10 96034815 | ptesraa97@gmail.com | |
| Asmaa Khalil Mohamed, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Afaf Mohamed Mahmoud, PhD | Ass. Professor, Cairo University | Study Chair |
| Elham Shahat Hassan, PhD | Lecturer, Cairo University | Study Director |
| Hossam Al Din Hussein Kamel, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy - Cairo University | Giza | Egypt |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Medical treatment | Drug | Duloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups. |
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| 8 weeks |
| Short Form-36 (SF-36) questionnaire | Health-related quality of life (HRQL) will be assessed using the Short Form-36 (SF-36) questionnaire, which evaluates eight domains including physical functioning, bodily pain, vitality, social functioning, emotional and physical role limitations, mental health, and general health perceptions. These domains are grouped into physical and mental health components. The 36-item questionnaire takes about five minutes to complete, and scores are converted to a 0-100 scale, where higher scores indicate better health status. | 8 weeks |
| Professor, Al-Azhar University |
| Study Director |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |