Video-Based Pelvic Floor Muscle Therapy for Adult Patients with Pelvic Floor Disorders: A Protocol for a Prospective Single-Arm Interventional Pilot and Feasibility Study

ABSTRACT

The number of patients who suffer from pelvic floor disorders increases with age and can have a significant impact on quality of life. The first-line treatment for these different disorders includes pelvic floor rehabilitation. However, there are high rates of non-compliance with completing the recommended duration of treatment due to delays in appointments and time constraints. Thus, the primary goal of this study is to evaluate the feasibility and acceptability of an online 8-week video-based pelvic floor muscle therapy program. A secondary goal is determining whether the treatment can improve quality of life and symptoms. This study is a registry-based pilot single-arm prospective trial (NCT06689891: Video-Based Pelvic Floor Muscle Therapy). Eligible participants will be offered the online program as an alternative to in-person pelvic floor rehabilitation. Primary timepoints include a pre-intervention in-person visit with a licensed pelvic floor therapist and the 8-week video-based pelvic floor muscle therapy program. There will be a midpoint evaluation followed by a post-intervention visit with the same pelvic floor therapist, where participants will be graded on their ability to complete the various exercises to assess efficacy. A survey assessing the online-based program’s usability will be conducted post-intervention. Patient-reported outcome measures, including quality-of-life and symptom changes, will be collected pre-, mid-, and post-intervention. As this is a pilot trial, the goal is to establish the acceptability and feasibility of a video-based pelvic floor muscle therapy program as an alternative to in-person treatment.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06689891

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Not Applicable

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This protocol has received approval from the Yale University Institutional Review Board (#2000037163).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

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