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

Sponsor

Pelex (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06097234

Collaborator

(none)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

The devices under study alone
The device under study plus 4 weekly visits with a pelvic floor physical therapist
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).

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Pelvic Floor Disorders	Device: Pelex Upp Behavioral: Pelvic Floor Physical Therapy	N/A

Detailed 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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Randomized controlled prospective trialRandomized controlled prospective trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 23, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pelex Upp Device 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.	Device: Pelex Upp Biofeedback-mediated pelvic floor trainer. It captures contraction and relaxation of the pelvic floor muscles during use by the subject, and represents these contractions and relaxations back to the subject to improve conscious control of the muscle groups.
Active Comparator: Pelex Upp Device + Pelvic Floor Physical Therapy 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.	Device: Pelex Upp Biofeedback-mediated pelvic floor trainer. It captures contraction and relaxation of the pelvic floor muscles during use by the subject, and represents these contractions and relaxations back to the subject to improve conscious control of the muscle groups. Behavioral: Pelvic Floor Physical Therapy A form of physical therapy whereby the subject is given instructions on how to identify the pelvic floor, how to coordinate the pelvic floor contractions and relaxations, as well as counseling on dietary changes that affect pelvic floor and pelvic organ function
Active Comparator: Pelvic Floor Physical Therapy 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.	Behavioral: Pelvic Floor Physical Therapy A form of physical therapy whereby the subject is given instructions on how to identify the pelvic floor, how to coordinate the pelvic floor contractions and relaxations, as well as counseling on dietary changes that affect pelvic floor and pelvic organ function

Arm

Intervention/Treatment

Active Comparator: Pelex Upp Device

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.

Device: Pelex Upp

Biofeedback-mediated pelvic floor trainer. It captures contraction and relaxation of the pelvic floor muscles during use by the subject, and represents these contractions and relaxations back to the subject to improve conscious control of the muscle groups.

Active Comparator: Pelex Upp Device + Pelvic Floor Physical Therapy

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.

Device: Pelex Upp

Behavioral: Pelvic Floor Physical Therapy

A form of physical therapy whereby the subject is given instructions on how to identify the pelvic floor, how to coordinate the pelvic floor contractions and relaxations, as well as counseling on dietary changes that affect pelvic floor and pelvic organ function

Active Comparator: Pelvic Floor Physical Therapy

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.

Behavioral: Pelvic Floor Physical Therapy

Outcome Measures

Primary Outcome Measures

Change in stress urinary incontinence symptoms [4 weeks]
Patients are given the ICIQ-UI SF, the standard assessment tool for stress and urge urinary incontinence, both before initiation and at the end of study, as well as the UDI, a measure of the impact of incontinence on quality of life. The difference between the two scores was then assessed to determine whether an change in stress urinary incontinence symptoms occurred after use of the device. ICIQ is the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form is a four question survey to "evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women." It has a maximum and minimum score of 21 and 0 respectively. Higher scores reflect more significant urinary incontinence symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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