Health TrialsbyHealthPanel

HOme PElvic Floor Improvement Trainer Trial

ConditionsPelvic PainPelvic Floor DysfunctionVoiding Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Voiding DysfunctionExperimental treatment 1 intervention
Group B: Pelvic painExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dysfunctional Voiding symptom scale (30 point scale)

this survey will be given to all participants and is the primary outcome of the DV group. This will be attained at the initial urology consult visit, 4-week, and 8-week visits. 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.

Time frame
0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey
2

McGill Pain Scale (Short Form- points scale)

this survey will be given to all participants and is the primary outcome of the Pelvic Pain group. This will be attained at the initial urology consult visit, 4-week, and 8-week visits. total of 22 items with 0-10 numerical response options, 0 being no pain and the higher score representing more pain)

Time frame
0 weeks baseline, 4 weeks, and 8 weeks patients will take the McGill pain Scale Short Form survey

Secondary outcomes

1

Post-Void Residual Volume (mL)

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.

Time frame
0 weeks baseline, 8 weeks in-person visits investigators will attain PVR
2

Uroflowmetry

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

Time frame
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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: