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

Starting soon · Not applicable

Conditions studied: Interstitial Cystitis/Painful Bladder Syndrome, Interstitial Cystitis, Chronic, High Tone Pelvic Floor Dysfunction

In brief

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.

Key facts

Study ID

NCT07038512

Run by

Wake Forest University Health Sciences

People needed

10

Starts

2026-08-01

Expected to finish

2027-01-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Biological Female
• Previously established clinical diagnosis of Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS)
• Diagnosed with High-tone Pelvic Floor Dysfunction (HTPFD)
• Current pelvic pain score of 5 or greater on an 11-point Likert Scale
• Must be willing and able to insert intravaginal device
• No cognitive deficits
• Agrees not to commence any new treatments for HTPFD or IC/BPS (medical or physical therapy) during the 12-week intervention period

You may not qualify if…

• History of a spinal cord injury
• Currently pregnant or lactating
• Allergy to device materials
• Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas, vaginitis, bacterial vaginosis, STIs, etc.)
• Have open wounds, cuts, or open sores present in the vaginal or pelvic area
• Recent pelvic or abdominal surgery within the last 3 months
• Currently under the care of a pelvic floor physical therapist or pelvic floor physiotherapist
• History of Neurogenic bladder
• History of bladder, uterine, ovarian or vaginal cancer
• History of radiation cystitis
• Any pelvic floor/bladder Botox use within 6 months of enrollment and no future plans for Botox injections during the study period.
• Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the Floora, at the discretion of the Investigator

Where it is running

• Atrium Health Wake Forest Baptist Urology — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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