About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Floora Pelvic Rehabilitation Vaginal Dilator
Treatment groups
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Hyivy Health Inc
Collaborator