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

The purpose of this study is to test the safety and effectiveness of the Floora Pelvic Rehabilitation Vaginal Dilator in females with Interstitial Cystitis/ Bladder pain Syndrome (IC/BPS) and High-tome Pelvic Floor Dysfunction (HTPFD). After enrollment, participants will be given a Floora device and will be instructed to use the device at least three times per week for 12-weeks in the comfort of their home. Each session consists of 10 minutes of heat and 10 minutes of dilation. All participants will be required to attend 3 in-person clinic visits and there will be two follow-up phone-calls throughout the 16-week trial period.

NCT Number	NCT07038512
Lead Sponsor	Wake Forest University Health Sciences Collaborators: Hyivy Health Inc
Conditions	Interstitial Cystitis/Painful Bladder Syndrome, Interstitial Cystitis, Chronic, High Tone Pelvic Floor Dysfunction
Enrollment	10 participants
Start Date	2026-08
Primary Completion	2026-12 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-26