Stress Urinary IncontinenceNCT07455838
Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence
A study testing Pelvic floor muscle rehabilitation supported by an immersive VR and Medical treatment in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) . Read more about this study
- Who is it for?
- Ages 22 to 35 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic floor muscle rehabilitation supported by an immersive VR and Medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asmaa Khalil Mohamed, PhD contact
Egypt1 site
Faculty of Physical Therapy - Cairo University
Giza
Esraa Adel Khamees, B.Sc, +20 10 96034815, ptesraa97@gmail.com
Asmaa Khalil Mohamed, PhD
About this study
Official title: Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence: A Randomized Controlled Trial
This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic floor muscle rehabilitation supported by an immersive VR, Medical treatment
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle rehabilitation supported by an immersive VROther
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.
Medical treatmentDrug
Also called Duloxetine
Duloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pelvic floor muscle rehabilitation supported by an immersive VR; Drug: Medical treatment |
| Medical treatment | Other | Participants in this group will receive medical treatment for SUI. Receives: Drug: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 8 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion10 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Adel Khamees, Cairo University
- Investigators
- Afaf Mohamed Mahmoud, PhD, Study chair, Ass. Professor, Cairo UniversityElham Shahat Hassan, PhD, Study director, Lecturer, Cairo UniversityHossam Al Din Hussein Kamel, PhD, Study director, Professor, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455838
- Sponsor's protocol ID
- P.T.REC/012/006275
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Mar 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07455838
- Acronym / sponsor ID
- P.T.REC/012/006275
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 6 Mar 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment | Experimental | Other: Pelvic floor muscle rehabilitation supported by an immersive VR, Drug: Medical treatmentParticipants 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. |
| Medical treatment | Other | Drug: Medical treatmentParticipants in this group will receive medical treatment for SUI. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Pelvic floor muscle rehabilitation supported by an immersive VRThe 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. | Other | Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment |
| Medical treatmentAlso: DuloxetineDuloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups. | Drug | Medical treatment, Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment |
Primary outcome
Assessment of pelvic floor muscle strength
Time frame: 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.
2 secondary outcomes
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: 8 weeks
Short Form-36 (SF-36) questionnaire
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Asmaa Khalil Mohamed, PhD contact
Afaf Mohamed Mahmoud, PhD study chair
Ass. Professor, Cairo University
Elham Shahat Hassan, PhD study director
Lecturer, Cairo University
Hossam Al Din Hussein Kamel, PhD study director
Professor, Al-Azhar 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 Pelvic floor muscle rehabilitation supported by an immersive VR and Medical treatment in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Mar 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Adel Khamees, B.Sc (+20 10 96034815, ptesraa97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pelvic floor muscle strength (time frame: 8 weeks). 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 6 Mar 2026.