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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Floora Pelvic Rehabilitation Vaginal Dilator to see if it is safe and helpful for women who have a condition called Interstitial Cystitis or Bladder Pain Syndrome (which causes bladder pain) along with tight muscles in the pelvic floor (the muscles that support your bladder and other organs). The goal is to find out if using this device can reduce pain and improve comfort.

Women who might be eligible for this study are those who have been diagnosed with both bladder pain syndrome and tight pelvic floor muscles, have a moderate to high level of pelvic pain, and are comfortable using a small device inserted vaginally. Participants will use the Floora device at home at least three times a week for 12 weeks. Each time, the device will provide gentle heat for 10 minutes followed by 10 minutes of stretching. During the study, participants will visit the clinic three times and receive two follow-up phone calls to check on their progress. It’s important to note that women who are pregnant, have certain infections, recent surgeries, or other health issues may not be able to join. Also, participants should not start any new treatments for their condition during the study. This trial aims to offer a new way to manage pain and improve quality of life for women with these challenging pelvic conditions.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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