Virtual Reality for Urinary Incontinence in Women

NCT07070063 | Recruiting

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

Brief Summary

This study evaluates the effectiveness of using virtual reality to support pelvic floor muscle training in women with urinary incontinence. The intervention aims to enhance patients' motivation, awareness, and exercise accuracy through real-time muscle visualization and immersive interaction. The project seeks to determine whether virtual reality-assisted therapy improves clinical outcomes compared to conventional approaches.

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) at 2 weeks

  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.

  From enrollment to the end of treatment at 2 weeks.

Secondary Outcomes (10)

• Change from Baseline in the Incontinence Impact Questionnaire - Short Form (IIQ-7) at 2 weeks

  From enrollment to the end of treatment at 2 weeks.

• Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) at 2 weeks

  From enrollment to the end of treatment at 2 weeks.

• Change from Baseline in the Gaudenz Questionnaire for the Assessment of Urinary Incontinence Severity at 2 weeks

  From enrollment to the end of treatment at 2 weeks.

• Change from Baseline in the King's Health Questionnaire (KHQ) at 2 weeks

  From enrollment to the end of treatment at 2 weeks.

• Change from Baseline in the Perceived Stress Questionnaire for Women (KPS) at 2 weeks

  From enrollment to the end of treatment at 2 weeks.

Study Arms (2)

VR Group

EXPERIMENTAL

VR-Supported Pelvic Floor Training

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

Control Group

ACTIVE COMPARATOR

Conventional Pelvic Floor Training

Device: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

Interventions

Virtual Reality Therapy DEVICE

Eight sessions of virtual reality therapy will be administered over a two-week period (four sessions per week, each lasting 20 minutes). The intervention will be delivered using the VRTierOne device (Stolgraf®), which employs a head-mounted display to create a fully immersive environment. Through the integration of visual, auditory, and kinesthetic stimuli, the therapy provides a multi-sensory experience that can have calming and mood-enhancing effects, as well as support psychological engagement and motivation in the rehabilitation process. The virtual environment-designed as a therapeutic garden-is rich in symbols and metaphors derived from Ericksonian psychotherapy. The central element of this environment is the Garden of Revival, a metaphor for the patient's health. Once vibrant and full of life, the garden is now neglected and requires care and effort to be restored. Throughout the therapeutic process, the patient is guided by a symbolic narrative reflecting their individual

VR Group

Pelvic Floor Muscle Electrostimulation with EMG Biofeedback DEVICE

Eight sessions of pelvic floor muscle electrostimulation combined with EMG biofeedback will be provided over a two-week period (four sessions per week). The intervention will be delivered using a specialized EMG-Biofeedback electrostimulation device equipped with a screen for real-time signal visualization. Vaginal electrodes will be used to ensure precise stimulation and accurate detection of pelvic floor muscle activity. During each 30-minute session, patients will receive symmetrical biphasic rectangular electrical impulses at a frequency of 50 Hz, with a 5-second stimulation phase followed by a 10-second rest period. The intensity of the stimulation will be individually adjusted to ensure both safety and comfort. The integrated biofeedback system will allow participants to observe their muscle activation patterns on the screen, enhancing their awareness and control of pelvic floor function and supporting the learning of correct activation during voluntary contractions.

Control Group; VR 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 IIa according to the ICS 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
• Independent Public Health Care Center of the Ministry of the Interior and Administration in Wrocław: collaborator
• Jan Dlugosz University in Czestochowa: collaborator
• Wroclaw Medical University: 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

RECRUITING

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 (Poland)

  PRINCIPAL INVESTIGATOR

• Waldemar Andrzejewski, Professor

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Kołodyńska, PhD

CONTACT

608134579; gabriela.kolodynska@awf.wroc.pl

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: Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 17, 2025
• Study Start: July 15, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 15, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

PL (1)