HOme PElvic Floor Improvement Trainer Trial (HoPE FIT)

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Pelvic Pain; Pelvic Floor Dysfunction; Voiding Dysfunction

Treatments: Device: Home Pelvic Floor Trainer

Study type: Interventional

Funder types: Other

Identifiers

NCT06909539

24-1026

Details and patient eligibility

About

This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain. We 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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Voiding Dysfunction

Experimental group

Description:

Patients with voiding dysfunction only and no pelvic pain symptoms will use the home pelvic floor trainer daily for 2 months.

Treatment:

Device: Home Pelvic Floor Trainer

Pelvic pain

Experimental group

Description:

Patients with pelvic pain with or without voiding dysfunction symptoms will use the home pelvic floor trainer daily for 2 months.

Treatment:

Device: Home Pelvic Floor Trainer