Virtual Pelvic Floor Therapy vs. Device for Stress Incontinence

N/A

Recruiting

Research Sponsored by Pelex

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of a device plus physical therapy vs physical therapy alone for stress urinary incontinence. Participants will complete a questionnaire at the end to measure outcome.

Who is the study for?

This trial is for women over 18 with stress urinary incontinence, confirmed by the ICIQ questionnaire. It's not suitable for those who've had pelvic or lower back surgery, are pregnant, have done regular Kegel exercises or supervised pelvic training, had certain types of childbirth procedures, or have significant pelvic organ prolapse.

What is being tested?

The study compares a device called Pelex Upp to standard pelvic floor physical therapy in treating stress urinary incontinence. Participants will either use the device alone, combine it with weekly physical therapy visits, or only attend physical therapy sessions and follow a specific muscle training routine.

What are the potential side effects?

While side effects aren't detailed here, typical ones from such interventions might include discomfort during use of the device or soreness from physical therapy exercises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in stress urinary incontinence symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Pelvic Floor Physical TherapyActive Control1 Intervention

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.

Group II: Pelex Upp Device + Pelvic Floor Physical TherapyActive Control2 Interventions

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.

Group III: Pelex Upp DeviceActive Control1 Intervention

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.

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