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.

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

Assigned female at birth

Data obtained through this study may be provided to qualified researchers with academic interest in pelvic floor muscle weakness, home exercise adherence, and smartphone application use for home exercise adherence. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Sarah Walker at sarahmwalker86@gmail.com

Participants were blinded to their group allocation and were not aware that another treatment existed until debriefing and unblinding.