Clinical trial NCT06909539: HOme PElvic Floor Improvement Trainer Trial
Official title: Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Pain
Pelvic Floor Dysfunction
Voiding Dysfunction
Keywords: voiding dysfunction
pelvic floor dysfunction
pelvic pain
perineometer
gamification
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dysfunctional Voiding symptom scale (30 point scale)
timeFrame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey
measure: McGill Pain Scale (Short Form- points scale)
timeFrame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the McGill pain Scale Short Form survey
Secondary outcomes:
measure: Post-Void Residual Volume (mL)
timeFrame: 0 weeks baseline, 8 weeks in-person visits investigators will attain PVR
measure: Uroflowmetry
timeFrame: Investigators will attain uroflowmetry at the same time as the PVR measurement, at initial baseline (0 weeks) and last (8 weeks) in-person visits.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kelly Harris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skardoon GR, Khera AJ, Emmanuel AV, Burgell RE. Review article: dyssynergic defaecation and biofeedback therapy in the pathophysiology and management of functional constipation. Aliment Pharmacol Ther. 2017 Aug;46(4):410-423. doi: 10.1111/apt.14174. Epub 2017 Jun 29.
citation: Vasconcelos M, Lima E, Caiafa L, Noronha A, Cangussu R, Gomes S, Freire R, Filgueiras MT, Araujo J, Magnus G, Cunha C, Colozimo E. Voiding dysfunction in children. Pelvic-floor exercises or biofeedback therapy: a randomized study. Pediatr Nephrol. 2006 Dec;21(12):1858-64. doi: 10.1007/s00467-006-0277-1. Epub 2006 Sep 12.
citation: 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.
citation: 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.