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

Inclusion Criteria:

• Biological Female

• Previously established clinical diagnosis of Interstitial Cystitis/ Bladder PainSyndrome (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 physicaltherapy) 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 floorphysiotherapist

• 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 plansfor Botox injections during the study period.

• Any other medical condition or clinical finding giving reasonable suspicion of adisease or condition that contraindicates the use of the Floora, at the discretionof the Investigator