Pelvic PainHoPe FITNCT06909539
HOme PElvic Floor Improvement Trainer Trial
A study testing Home Pelvic Floor Trainer in people with Pelvic Pain and Pelvic Floor Dysfunction, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction
- What is being tested?
- Home Pelvic Floor Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80011
Kelly Harris, MD, 720-777-3926, kelly.harris2@childrenscolorado.org
About this study
Official title: Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction
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.
Read the detailed 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.
- Conditions
- Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction
- Being tested
- Home Pelvic Floor Trainer
- Keywords
- voiding dysfunction, pelvic floor dysfunction, pelvic pain, perineometer, gamification, pelvic floor physical therapy
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Voiding Dysfunction | Experimental | Patients with voiding dysfunction only and no pelvic pain symptoms will use the home pelvic floor trainer daily for 2 months. Receives: 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. Receives: Device: Home Pelvic Floor Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 before the start of treatment, at 4-week mark, and at 8-week visit. 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.
Measured: 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 before the start of treatment, at 4-week mark, and 8-week visit. Total of 22 items with 0-10 numerical response options, 0 being no pain and the higher score representing more pain)
Measured: 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)
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.
Measured: 0 weeks baseline, 8 weeks in-person visits investigators will attain PVR
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
Measured: Investigators will attain uroflowmetry at the same time as the PVR measurement, at initial baseline (0 weeks) and last (8 weeks) in-person visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Harris, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909539
- Sponsor's protocol ID
- 24-1026
- Acronym
- HoPe FIT
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28660663Vasconcelos 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.
PubMed 16967285Wagner 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.
PubMed 33751183Taylor 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.
PubMed 30350888
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT06909539
- Acronym / sponsor ID
- HoPe FIT / 24-1026
- Conditions
- Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction
- Keywords
- voiding dysfunction, pelvic floor dysfunction, pelvic pain, perineometer, gamification, pelvic floor physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voiding Dysfunction | Experimental | Device: Home Pelvic Floor TrainerPatients with voiding dysfunction only and no pelvic pain symptoms will use the home pelvic floor trainer daily for 2 months. |
| Pelvic pain | Experimental | Device: Home Pelvic Floor TrainerPatients with pelvic pain with or without voiding dysfunction symptoms will use the home pelvic floor trainer daily for 2 months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Pelvic Floor TrainerThe 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. | Device | Pelvic pain, Voiding Dysfunction |
Primary outcome
Dysfunctional Voiding Symptom Scale (30 point scale)
Time frame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey
This survey will be given to all participants and is the primary outcome of the DV group. This will be attained before the start of treatment, at 4-week mark, and at 8-week visit. 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.
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
This survey will be given to all participants and is the primary outcome of the Pelvic Pain group. This will be attained before the start of treatment, at 4-week mark, and 8-week visit. Total of 22 items with 0-10 numerical response options, 0 being no pain and the higher score representing more pain)
2 secondary outcomes
Post-Void Residual Volume (mL)
Time frame: 0 weeks baseline, 8 weeks in-person visits investigators will attain PVR
Uroflowmetry
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 28660663Skardoon 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.
- Background: PubMed 16967285Vasconcelos 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.
- Background: PubMed 33751183Wagner 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.
- Background: PubMed 30350888Taylor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Harris, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Pelvic Floor Trainer in people with Pelvic Pain and Pelvic Floor Dysfunction, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Harris, MD ((720)777-3926, kelly.harris2@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06909539, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.