Virtual Reality for Urinary Incontinence in Women

NCT07070063 | Completed

• 1 other identifier: 49/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This assessor-blinded, non-randomized, parallel-group controlled study evaluated whether adding immersive virtual reality to pelvic floor muscle electrostimulation with electromyographic biofeedback improved incontinence-related quality of life in postmenopausal women with urinary incontinence. Participants received electrostimulation with EMG biofeedback alone or the same intervention preceded by a 20-minute immersive VR session.

Conditions

Urinary Incontinence; Pelvic Floor Disorder

Keywords

Virtual Reality; Rehabilitation; Pelvic Floor Muscle Training; Urinary incontinence; Women's health

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score

  The I-QOL is a 22-item instrument designed to assess the impact of urinary incontinence on quality of life in women. It covers three domains: avoidance and limiting behaviors, psychosocial impacts, and social embarrassment. Items are rated on a 5-point Likert scale (1 = extremely to 5 = not at all). Scores are transformed into a scale ranging from 0 to 100, with higher scores indicating better quality of life.

  Baseline and immediately after the 2-week intervention

Secondary Outcomes (10)

• Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score at 2-Week Post-Intervention Follow-Up

  Baseline and 2 weeks after completion of the intervention

• Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Subscale Scores

  Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.

• Change from Baseline in the Incontinence Impact Questionnaire-Short Form (IIQ-7) Total Score

  Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention

• Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-Short Form (PISQ-12) Total Score

  Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention

• Change from Baseline in the King's Health Questionnaire (KHQ) Domain Scores

  Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention

Study Arms (2)

VR + ES Group

EXPERIMENTAL

Participants received immersive virtual reality immediately before pelvic floor muscle electrostimulation and EMG biofeedback.

Device: Immersive Virtual Reality Therapy; Device: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

ES Group

ACTIVE COMPARATOR

Participants received pelvic floor muscle electrostimulation followed by EMG biofeedback without virtual reality.

Device: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

Interventions

Pelvic Floor Muscle Electrostimulation with EMG Biofeedback DEVICE

Eight sessions of pelvic floor muscle electrostimulation followed by EMG biofeedback were delivered over 2 weeks (four sessions/week) using the NeuroTrac® MyoPlus 4 Pro and an individually assigned intravaginal probe. Stimulation consisted of symmetrical biphasic rectangular pulses at 50 Hz and 250 μs, with 5 seconds of stimulation, 10 seconds of rest, and 1-second ramp-up and ramp-down periods. Each electrostimulation session lasted 20 minutes. Intensity was increased to the highest comfortably tolerated level producing a visible or palpable pelvic floor muscle contraction. This was followed by approximately 5 minutes of EMG biofeedback training with real-time visualization of muscle activity.

ES Group; VR + ES Group

Immersive Virtual Reality Therapy DEVICE

Eight approximately 20-minute immersive virtual reality sessions were administered over a 2-week period, with four sessions per week. The intervention was delivered using the VRTierOne system (Stolgraf®) immediately before pelvic floor muscle electrostimulation and EMG biofeedback. The virtual environment consisted of a gradually evolving therapeutic garden and included mandala-painting tasks and guided breathing exercises intended to support relaxation and engagement in the rehabilitation process. The VR system was not technically integrated with the EMG biofeedback device and did not provide real-time visualization of pelvic floor muscle activity.

VR + ES Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50-80 years, who are at least 12 months post-menopausal,
• Diagnosed with urinary incontinence of grade I or II according to the Stamey classification,
• No contraindications to participation (e.g., acute urinary tract infections, severe neurological disorders),
• Provision of written informed consent to participate in the research experiment.

You may not qualify if:

• Urinary incontinence of grade III or higher,
• Presence of significant neurological conditions affecting bladder control,
• Participation in other therapeutic interventions that could interfere with study outcomes,
• Pregnancy,
• Refusal or inability to provide informed consent.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Wroclaw Medical University: collaborator
• Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław: collaborator
• Jan Dlugosz University in Czestochowa: collaborator

Study Sites (1)

Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław

Wroclaw, Lower Silesian Voivodeship, 50-233, Poland

Location

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

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; Pregnancy Complications

Study Officials

• Gabriela Kołodyńska, PhD

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

• Joanna Szczepańska-Gieracha, Professor

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

• Maciej Zalewski, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Waldemar Andrzejewski, Professor

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants were assigned to the intervention groups based on the organizational and technical availability of the virtual reality system during the recruitment period. No random sequence generation or allocation concealment was used.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 17, 2025
• Study Start: July 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

PL (1)