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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorWake Forest University Health Sciences

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

Sponsors and collaborators