Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT06097234
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
Sponsor:
Pelex
Organization:
Study Overview
Official Title:
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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).
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).
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:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: