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

10 Participants
are divided into 1 treatment group

Locations

1
Atrium Health Wake Forest Baptist Urology27103, Winston-SalemNorth Carolina, United States

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

Hyivy Health Inc

Collaborator