Virtual Reality for Urinary Incontinence in Women

NCT07070063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-24

No results posted yet for this study

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

Interventions

DEVICE

Immersive Virtual Reality Therapy

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.

DEVICE

Pelvic Floor Muscle Electrostimulation with EMG Biofeedback

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.

Sponsors & Collaborators

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

    collaborator UNKNOWN
  • Jan Dlugosz University in Czestochowa

    collaborator OTHER
  • Wroclaw Medical University

    collaborator OTHER
  • Wroclaw University of Health and Sport Sciences

    lead OTHER

Principal Investigators

  • Gabriela Kołodyńska, PhD · Wroclaw University of Health and Sport Sciences, Poland

  • Joanna Szczepańska-Gieracha, Professor · Wroclaw University of Health and Sport Sciences, Poland

  • Maciej Zalewski, PhD · Wroclaw Medical University

  • Waldemar Andrzejewski, Professor · Wroclaw University of Health and Sport Sciences, Poland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-11-30
Completion
2026-02-28

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070063 on ClinicalTrials.gov