Stress urinary incontinence, which affects one in four adults in the US, is the involuntary loss of urine during coughing, sneezing, or high impact activity.

Studies show that 84% of those affected by stress urinary incontinence will have improvement in their symptoms with pelvic floor muscle training (PFMT for short), if done correctly. Many people, however, have difficulty consistently doing their PMFT correctly.

PFMT involves exercising the pelvic muscles with the aim of strengthening and helping with the coordination of those muscles around the bladder sphincter. There are many types of PFMT such as Kegel exercises. PFMT is considered the standard treatment for stress urinary incontinence.

We will ask you to first fill out a confidential questionnaire to make sure there isn’t any medical reason you shouldn’t participate.  Then a doctor will contact you to go over the specifics of the study, and have you sign a consent form to participate in the study.  At any point, including after signing the consent form, you have the right to opt out of the study.  

During the study, we will ask you to:

- Perform pelvic floor muscle training, with or without the Pelex Upp, ten minutes a day, four days a week, for four weeks.

- If assigned to treatment with a pelvic floor physical therapist, meet with the physical therapist once a week for four weeks.  The visits will be between 30-45 minutes and can be scheduled at your convenience. All visits will be conducted by video, meaning you will not need to leave your home for treatment.

- Answer questions regarding your incontinence symptoms at the beginning and end of the study.

You will be provided with all necessary equipment to complete the study free of charge, including instructional materials, pelvic floor physical therapist visits and, if selected, a Pelex Upp for use during the study.

The Pelex Upp is a medical device that was developed by Pelex, Inc. to help the user correctly perform pelvic floor muscle training in the privacy of their home. The Pelex Upp is non-invasive, hygienic, and comes with programmed exercises that increase pelvic floor muscle strength and responsiveness.

No.

There are three possible treatments you can receive in this study- the Pelex Upp by itself, the Pelex Upp plus weekly telehealth visits with a pelvic floor physical therapist, or weekly telehealth visits with a pelvic floor physical therapist alone. After agreeing to be in the study, you will be randomly assigned to one of the three treatments.  You cannot choose to receive a specific treatment.

Pelex is a medical device company that aims to address pelvic floor disorders including urinary incontinence and overactive bladder.

We hope that this will improve any stress urinary incontinence symptoms you may have.  You will also help us get one step closer to being able to offer this to anyone with stress urinary incontinence!

Also, participation in this study is completely free.

We really appreciate your interest in participating in our study!

If you would like to participate, please click the link below.  It will take you to a screening questionnaire to determine whether or not you qualify for the study.

Once that is completed, someone from our team will contact you within 24 hours.

Thanks again for your interest!

LINK: https://forms.gle/vmUL68i35umkJ1kTA