Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction

NANot yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

May 31, 2026

Study Completion Date

June 30, 2026

Conditions
Interstitial Cystitis/Painful Bladder SyndromeInterstitial Cystitis, ChronicHigh Tone Pelvic Floor Dysfunction
Interventions
DEVICE

Floora Pelvic Rehabilitation Vaginal Dilator

The Floora Pelvic Rehabilitation Vaginal Dilator, created by Hyivy Health Inc, is a multi-therapy hand held ergonomic intravaginal wand device that is designed to be used in the comfort of the user's home. The Floora has two main therapeutic functions, controllable dilation and thermal therapy. It is the first vaginal dilator that performs auto-dilation using one or two air chambers inflated from the device surface by an internal pump, eliminating the need for reinsertion. The device is equipped with biosensors that measure the pressure from the vaginal canal which allows this device to provide a gradual and gentle stretch to the pelvic floor muscles. The thermal therapy is achieved through an electrical circuit, changing the temperature of the device in small increments. Users are able to force-stop and change the temperature and dilation settings during a session.

Trial Locations (1)

27103

Atrium Health Wake Forest Baptist Urology, Winston-Salem

All Listed Sponsors
collaborator

Hyivy Health Inc

INDUSTRY

lead

Wake Forest University Health Sciences

OTHER

NCT07038512 - Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction | Biotech Hunter | Biotech Hunter