Recruiting

Biofeedback

Sponsor:

University of Colorado, Denver

Code:

NCT06909539

Conditions

Pelvic Pain

Pelvic Floor Dysfunction

Voiding Dysfunction

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Home Pelvic Floor Trainer

Study Details

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.

Conditions

Pelvic Pain

Pelvic Floor Dysfunction

Voiding Dysfunction

Study ID

NCT06909539

Start date

Nov 1, 2026

Status verified date

Oct, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Voiding Dysfunction

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

experimental: Pelvic pain

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

Interventions

Home Pelvic Floor Trainer

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 outcome measure

  • Dysfunctional Voiding Symptom Scale (30 point scale) [ Time Frame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey ]
  • 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 ]

Central Contacts and Locations

Central contacts

Kelly Harris, MD

(720)777-3926kelly.harris2@childrenscolorado.org

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80011

Contacts

Kelly Harris, MD

720-777-3926kelly.harris2@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • voiding dysfunction
  • pelvic floor dysfunction
  • pelvic pain
  • perineometer
  • gamification
  • pelvic floor physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.