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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-35
SponsorCairo University

About this trial

This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Pelvic floor muscle rehabilitation supported by an immersive VR

    Other intervention

    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 treatment

    Drug

    Duloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatmentExperimental treatment 2 interventions
Group B: Medical treatmentOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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