HOme PElvic Floor Improvement Trainer Trial

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.

• 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

• 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 before the start of treatment, at 4-week mark, and at 8-week visit. 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 before the start of treatment, at 4-week mark, and 8-week visit. Total of 22 items with 0-10 numerical response options, 0 being no pain and the higher score representing more pain)

Secondary outcomes

• Post-Void Residual Volume (mL) [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.
• Uroflowmetry [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

Sex: All, ages: 8 Years to 18 Years

Inclusion Criteria:

* English-speaking only.
* 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.
* Patient received PVR and uroflow at initial urology consult visit.
* Patient or parent has an Apple product (ie: iPhone, or tablet). The application is only available via Apple products.

Exclusion Criteria:

* Non-English speaking.
* 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.

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• Wagner B, Steiner M, Huber DFX, Crevenna R. The effect of biofeedback interventions on pain, overall symptoms, quality of life and physiological parameters in patients with pelvic pain : A systematic review. Wien Klin Wochenschr. 2022 Jan;134(Suppl 1):11-48. doi: 10.1007/s00508-021-01827-w. Epub 2021 Mar 22. PMID 33751183
• Taylor AS, Cabo JJ, Lauderdale C, Maskan N, Thomas JC, Tanaka ST, Pope JC, Adams MC, Brock JW, Shannon CN, Clayton DB. Pelvic floor biofeedback therapy in children: Assessment of symptom scores in responders and non-responders. Neurourol Urodyn. 2019 Jan;38(1):254-260. doi: 10.1002/nau.23842. Epub 2018 Oct 23. PMID 30350888

• Kelly Harris, MD, Principal investigator, University of Colorado, Denver