CompletedNot Applicable

Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT

United States33 participantsStarted 2022-05-11

Plain-language summary

The goal of this randomized clinical trial is to investigate the impact of a smartphone-based application on patient-reported outcomes for patients with pelvic floor muscle weakness, and the relationship of patient adherence to outcomes in pelvic floor physical therapy compared to the paper-based standard of care. An additional aim is the exploration and development of two patient-reported questionnaires to enhance understanding of exercise adherence in outpatient pelvic floor physical therapy and smartphone application self-efficacy. These goals will serve to improve practice recommendations for home exercise prescriptions in this patient population. Participants will be asked to complete 6 patient-reported outcome measures after they complete four, 60-minute long physical therapy treatment sessions conducted one time per week according to the current standard of care for pelvic floor physical therapy. The experimental group will be given a free pelvic floor muscle exercise application while the control group will be provided with the paper-based standard of care for their home exercise program.

Who can participate

Age range

18 Years – 85 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-85 years old * Referred to outpatient pelvic floor physical therapy for treatment of pelvic floor weakness * Generation 5 or later iPhone, Android, or Smart Device * Must be willing to receive Push Notification reminders from the application * Must have free space on device to download and install app * Must have access to the Google Play store or to iOS Apple App Store Exclusion Criteria: * ● Not Meeting Inclusion Criteria * Pelvic Organ Prolapse Surgery with complications * Neurodegenerative Disease * History of TBI or CVA with resulting impairment in long- or short-term memory * Denervation injury to the pelvic floor * Spinal cord injury * Pelvic Pain Condition * Incapable of Completing Outcomes Questionnaire without caregiver support * Unable to speak and read English * Current Pregnancy * Less than 6 weeks postpartum * Researcher judgement

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pelvic Floor Distress Inventory short-form 20 (PFDI-20)

Timeframe: From date of randomization through study completion, an average of 3 months.

Trial details

NCT IDNCT06162845

SponsorUniversity of Central Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

View on ClinicalTrials.gov More Pelvic Floor Muscle Weakness trials