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Not yet recruiting NCT07455838

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

No phase Interventional Stress Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pelvic floor muscle rehabilitation supported by an immersive VR, Medical treatment.
Who it may be relevant to
Registry conditions: Stress Urinary Incontinence. Basic parameters: 22 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Pelvic 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 rand
  • Drug Medical treatment
    Duloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups.

Primary outcome measures

  • Assessment of pelvic floor muscle strength [Time frame: 8 weeks]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy - Cairo University — Giza

Identifiers

NCT: NCT07455838 · P.T.REC/012/006275

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗