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Home Pelvic Floor Trainer for Pelvic Pain and Voiding Dysfunction

This study is testing a device called the Home Pelvic Floor Trainer to see if it can help children and teenagers (ages 8-18) who experience pelvic pain or problems with bladder control (voiding dysfunction). The device uses external sensors to measure pelvic floor muscle strength and gives real-time feedback through a smartphone app during exercises. The study wants to find out if using this device can reduce pelvic pain, improve bladder control, and help the body function better during urination. We will measure improvements using surveys about symptoms and pain at the start, 4 weeks, and 8 weeks. The study is looking for 150 participants and its current status is unclear.

Study design
This interventional study plans to enroll 150 participants aged 8 to 18 years old. It will test the Home Pelvic Floor Trainer device.
What's involved
You would use the Home Pelvic Floor Trainer device and complete surveys at the start of the study, after 4 weeks, and after 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks, with assessments at baseline, 4 weeks, and 8 weeks.

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NCT06909539

HOme PElvic Floor Improvement Trainer Trial

Not Yet Recruiting
NAAges 8–18InterventionalTreatment
University of Colorado, Denver
~150 participants
Updated 2025-04-24 on ClinicalTrials.gov
What's tested:Home Pelvic Floor Trainer

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dysfunctional Voiding symptom scale (30 point scale)
Measured over 0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey
+1 more outcome measured

Conditions

Pelvic Pain
Pelvic Floor Dysfunction
Voiding Dysfunction

Explore related trials

Dysfunctional voiding of urinePelvic floor dysfunctionPelvic Pain

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Kelly Harris, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Kelly Harris, MD
[email protected]
(720)777-3926
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Dysfunctional Voiding symptom scale (30 point scale)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.

  • McGill Pain Scale (Short Form- points scale)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)