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NCT Number: NCT06909539

HOme PElvic Floor Improvement Trainer Trial

This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain. Investigators will test the utility of this device as a treatment alternative and/or temporary treatment for a patient's symptoms prior to or perhaps in lieu of their physical therapy appointment.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study aims to determine if a special device can help children with pelvic floor problems. The pelvic floor issues under investigation include difficulty controlling urination and ongoing pain in the lower belly. The study will explore whether the device helps children gain better control over urination.

It will also investigate if the device contributes to the reduction of pelvic pain experienced by children. Furthermore, the study will analyze if the device leads to improvement in how the body functions during urination. The consistency with which children use the device and adhere to instructions will be monitored. Finally, the study includes an assessment of whether children find the device acceptable for use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dysfunctional voiding symptoms without chronic pelvic pain.
  • Chronic pelvic pain with or without dysfunctional voiding symptoms.
  • Daytime enuresis, nocturnal enuresis, frequency, urgency, dysuria
  • 8 years - 18 years, no one under 8 and no one over 18.

Exclusion criteria

  • Has seen a physical therapist for traditional physical therapy of the pelvic floor due to urinary symptoms or chronic pelvic pain within the last 12 months.

Note: This would include patients who begin physical therapy for their pelvic floor outside of the study while enrolled in the study.

-All patients with the following conditions: severe developmental delay such as CP or wheelchair bound, cannot eat by mouth, mechanical ventilation dependence, etc.

  • Nonverbal or unable to effectively communicate needs and preferences.
  • Within the voiding dysfunction group, a diagnosis of a congenital GU anomaly (bladder exstrophy, cloacal anomaly, spina bifida, etc.)
  • No initial medication usage will be excluded; however, if the patient begins a new medication or treatment regimen during the study, the patient will be excluded.

Treatment and study plan

Home Pelvic Floor Trainer

Device

The intervention utilizes a perineometer device with biofeedback features.

This device employs external electrodes to measure pelvic floor muscle strength. It then provides real-time feedback through a smartphone application during exercise sessions. The application uses gamification to engage users and track progress. Patients can choose between two games: a bird game or a space-themed game. In the bird game, patients activate their pelvic floor muscles to make the bird fly upward. In the space game, pelvic floor contractions fire a laser or activate a shield. A visual bar displays the strength of pelvic floor contractions. Games are designed to be played for 5 minutes daily, 7 days a week, with increasing difficulty as the user progresses through levels.

Primary outcomes

  1. Dysfunctional Voiding symptom scale (30 point scale)

    Time frame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey

    this survey will be given to all participants and is the primary outcome of the DV group. This will be attained at the initial urology consult visit, 4-week, and 8-week visits. The DVSS is a 30 point scale with higher scores representing more severe voiding dysfunction symptoms. Males with score greater than 9 points are considered to have voiding dysfunction, and females with score greater than 6 are considered to have voiding dysfunction.

  2. McGill Pain Scale (Short Form- points scale)

    Time frame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the McGill pain Scale Short Form survey

    this survey will be given to all participants and is the primary outcome of the Pelvic Pain group. This will be attained at the initial urology consult visit, 4-week, and 8-week visits. total of 22 items with 0-10 numerical response options, 0 being no pain and the higher score representing more pain)

Secondary outcomes

  1. Post-Void Residual Volume (mL)

    Time frame: 0 weeks baseline, 8 weeks in-person visits investigators will attain PVR

    PVR volume > 10% normal will be considered elevated PVR. This will be attained from all participants at an initial baseline urology visit as part of standard of care, and the 8-week in-person visit.

  2. Uroflowmetry

    Time frame: Investigators will attain uroflowmetry at the same time as the PVR measurement, at initial baseline (0 weeks) and last (8 weeks) in-person visits.

    Uroflowmetry parameters will be assessed at the initial and 8-week visits. These parameters include:

    A normal, bell-shaped curve.

    A tower flow curve, suggesting detrusor overactivity.

    A staccato flow curve, suggesting external sphincter activity.

    An intermittent or interrupted flow curve, suggesting underactive detrusor or dysfunctional voiding.

    A plateau shape curve, suggesting bladder outlet obstruction

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Harris, MD

CONTACT

[email protected]

(720)777-3926

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction

Acronym: HoPE FIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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