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

NCT07455838 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006275
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Urinary Incontinence

Outcome Measures

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.

  8 weeks

Secondary Outcomes (2)

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

  8 weeks

• Short Form-36 (SF-36) questionnaire

  8 weeks

Study Arms (2)

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.

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.

Drug: Medical treatment

Interventions

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.

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

Medical treatment DRUG

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

Also known as: Duloxetine

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

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Afaf Mohamed Mahmoud, PhD

  Ass. Professor, Cairo University

  STUDY CHAIR

• Elham Shahat Hassan, PhD

  Lecturer, Cairo University

  STUDY DIRECTOR

• Hossam Al Din Hussein Kamel, PhD

  Professor, Al-Azhar University

  STUDY DIRECTOR

Central Study Contacts

Esraa Adel Khamees, B.Sc

CONTACT

+20 10 96034815; ptesraa97@gmail.com

Asmaa Khalil Mohamed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: March 10, 2026
• Primary Completion: May 10, 2026
• Study Completion: May 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

EG (1)