NCT06909539

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jun 2025Jan 2027

First Submitted

Initial submission to the registry

March 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

March 27, 2025

Last Update Submit

April 21, 2025

Conditions

Pelvic PainPelvic Floor DysfunctionVoiding Dysfunction

Keywords

voiding dysfunctionpelvic floor dysfunctionpelvic painperineometergamification

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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)

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

Secondary Outcomes (2)

  • Post-Void Residual Volume (mL)

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

  • Uroflowmetry

    Investigators will attain uroflowmetry at the same time as the PVR measurement, at initial baseline (0 weeks) and last (8 weeks) in-person visits.

Study Arms (2)

Voiding Dysfunction

EXPERIMENTAL

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

Device: Home Pelvic Floor Trainer

Pelvic pain

EXPERIMENTAL

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

Device: Home Pelvic Floor Trainer

Interventions

Home Pelvic Floor TrainerDEVICE

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.

Pelvic painVoiding Dysfunction

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Dysfunctional voiding symptoms without chronic pelvic pain.
  • Chronic pelvic pain with or without dysfunctional voiding symptoms.
  • Daytime enuresis, nocturnal enuresis, frequency, urgency, dysuria
  • years - 18 years, no one under 8 and no one over 18.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80011, United States

Location

Related Publications (4)

  • 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.

    PMID: 28660663BACKGROUND

  • 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.

    PMID: 16967285BACKGROUND

  • 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.

    PMID: 33751183BACKGROUND

  • 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.

    PMID: 30350888BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly Harris, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Harris, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)