CClinicalTrials.gg
Not yet recruitingNCT07455838Updated Mar 6, 2026

Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence

An interventional study of Pelvic floor muscle rehabilitation supported by an immersive VR and Medical treatment in Stress Urinary Incontinence, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 22 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
22 Years to 35 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Stress Urinary Incontinence
03

In context

Urinary Incontinence, Stress

658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 35 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment

    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.

    Other: Pelvic floor muscle rehabilitation supported by an immersive VR · Drug: Medical treatment

  • Other
    Medical treatment

    Participants in this group will receive medical treatment for SUI.

    Drug: Medical treatment

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.

    Also known as: Duloxetine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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).

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Faculty of Physical Therapy - Cairo University
    Giza, Egypt
    • Esraa Adel Khamees, B.Sc · Contact · ptesraa97@gmail.com · +20 10 96034815
    • Asmaa Khalil Mohamed, PhD · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07455838
Lead sponsor
Cairo University
Responsible party
Esraa Adel Khamees (Principal investigator, Cairo University) — Principal investigator
First posted
Mar 6, 2026
Start date
Mar 10, 2026 (estimated)
Primary completion
May 10, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Mar 6, 2026

Study contacts

Esraa Adel Khamees, B.Sc
Contact
ptesraa97@gmail.com
+20 10 96034815
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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