Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.

Pelex

Status: Enrolling

Conditions: Pelvic Floor Disorders; Stress Urinary Incontinence

Treatments: Device: Pelex Upp; Behavioral: Pelvic Floor Physical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06097234

PLX-002

Details and patient eligibility

About

The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical therapy.

The main questions it aims to answer are:

Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy?

Does treatment with the device under study combined with pelvic floor physical therapy improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy alone and treatment with the device alone?

Participants will be given one of three treatments:

1. The devices under study alone
2. The device under study plus 4 weekly visits with a pelvic floor physical therapist
3. Four weekly visits with a physical therapist alone Participants will perform a standardized pelvic floor muscle training program 10 minutes a day, four times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Full description

This will be a prospective cohort study of women > 18 years of age with symptoms of stress urinary incontinence, recruited via an online recruitment tool.

After screening, patients meeting inclusion criteria will be given instructions on how to indicate desire to participate in the study. The patient will then be contacted for study participation, including explanation of study and details and completion of Informed Consent. Participants will then complete a pre-treatment urinary incontinence symptom questionnaire(ICIQ).

After completion of the above, the participants will then be randomized to one of three arms:

1. Pelex Upp (study device) only
2. Pelvic floor physical therapy + Pelex Upp(device under study)
3. Pelvic floor physical therapy only

For those given a Pelex Upp, they will also receive educational materials on use of the device, and a treatment schedule. For those participants given a Pelex Upp, a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, four times a week for 4 weeks, will be performed. For those subjects undergoing pelvic floor physical therapy only, they will perform Kegel exercises on a similar schedule. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Endpoint of the study will be change in stress urinary incontinence symptoms as measured by the ICIQ. The ICIQ will be collected at 2 time points: before study entry, and at study close.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Female

• 18 years of age or older
• Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

Exclusion criteria

• History of pelvic or lower back surgery
• Pregnancy
• History of physician-supervised pelvic floor muscle training
• History of Kegel exercises greater than once a month
• History of prior operative delivery
• Self-reported history of pelvic organ prolapse stage II or greater

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Pelex Upp Device

Active Comparator group

Description:

Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.

Treatment:

Device: Pelex Upp

Pelex Upp Device + Pelvic Floor Physical Therapy

Active Comparator group

Description:

Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks. In addition, subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide further care instructions and pelvic floor training.

Treatment:

Behavioral: Pelvic Floor Physical Therapy

Device: Pelex Upp

Pelvic Floor Physical Therapy

Active Comparator group

Description:

Subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide care instructions and pelvic floor training, as well as provide a weekly treatment schedule for Kegel exercises.

Treatment:

Behavioral: Pelvic Floor Physical Therapy