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HOme PElvic Floor Improvement Trainer Trial

NCT06909539 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-24

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kelly Harris, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909539 on ClinicalTrials.gov