Ignite Creation Date:
2025-12-18 @ 9:20 AM
Ignite Modification Date:
2025-12-23 @ 10:51 PM
Study NCT ID:
NCT03877640
Status:
None
Last Update Posted:
2023-10-10 00:00:00
First Post:
2019-01-30 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Stress Incontinence and Urgency in Women With EMSELLA
Sponsor:
None
Organization:
Study Overview
Official Title:
A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)
Status:
None
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
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:
This is a blinded study to be conducted at San Diego Sexual Medicine in San Diego, CA. Participants meeting inclusion and exclusion criteria will receive one treatment cycle of active treatment or sham. The device will be equipped with 3 protocols in addition to the standard protocol, two of which are identical to the standard protocol (for active treatment) and one of which does not deliver HIFEM (for sham treatment). The active treatment arm consists of 6 treatments, 2 per week, with at least one day in between. Follow-up visits will occur at 4 weeks and 12 weeks after the last treatment. Unblinding will take place at the 12 week follow up visit, and subjects assigned to the sham arm will be crossed over to active treatment, beginning their first treatment on that day, completing 6 treatments and 2 follow up visits. Once unblinded the subject will be treated with the standard protocol of the device.
After the informed consent is signed, and inclusion and exclusion criteria completed, participants will complete validated questionnaires and undergo a baseline physical therapy assessment of pelvic floor muscle strength.
After the informed consent is signed, and inclusion and exclusion criteria completed, participants will complete validated questionnaires and undergo a baseline physical therapy assessment of pelvic floor muscle strength.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: