Stress Urinary Incontinence
Conditions
Brief summary
This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .
Detailed description
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.
Interventions
OTHERPelvic floor muscle rehabilitation supported by an immersive VR
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.
DRUGMedical treatment
Duloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Females, aged 22-35 years. * Postpartum period: between 3 and 6 months after vaginal delivery . * Able to perform basic pelvic floor contractions (Oxford Grade ≥ 2). * Women who are multiparous(2-3times) and have delivered vaginally. * Postpartum women with body mass index 18.5-30 kg/m²
Exclusion criteria
* Females Diagnosed with neurological conditions affecting pelvic control (e.g., multiple sclerosis, spinal cord injury). * History of pelvic floor surgery within the past 12 months. * Known visual, vestibular, or cognitive impairments that interfere with VR use. * Susceptibility to motion sickness or vertigo, worsened by visual simulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pelvic floor muscle strength | 8 weeks | 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 cmH₂O), 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | 8 weeks | 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). |
| Short Form-36 (SF-36) questionnaire | 8 weeks | 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. |
Countries
Egypt
Contacts
CONTACTEsraa Adel Khamees, B.Sc
CONTACTAsmaa Khalil Mohamed, PhD
STUDY_CHAIRAfaf Mohamed Mahmoud, PhD
Ass. Professor, Cairo University
STUDY_DIRECTORElham Shahat Hassan, PhD
Lecturer, Cairo University
STUDY_DIRECTORHossam Al Din Hussein Kamel, PhD
Professor, Al-Azhar University
Outcome results
None listed