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NCT Number: NCT07455838

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

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

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

22 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy - Cairo University

Giza, Egypt

Location contact

Asmaa Khalil Mohamed, PhD

CONTACT

Esraa Adel Khamees, B.Sc

CONTACT

[email protected]

+20 10 96034815

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

medical treatment

Drug

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

Other names: Duloxetine

Primary outcomes

  1. 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.

Secondary outcomes

  1. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: 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).

  2. Short Form-36 (SF-36) questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Khalil Mohamed, PhD

CONTACT

Esraa Adel Khamees, B.Sc

CONTACT

[email protected]

+20 10 96034815

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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