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Hyivy Floora for Interstitial Cystitis/Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction

This study is testing a device called the Floora Pelvic Rehabilitation Vaginal Dilator for women who have Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), which causes chronic bladder pain, and High-tone Pelvic Floor Dysfunction (HTPFD). The Floora device is an intravaginal wand that provides heat and controlled dilation to help manage symptoms at home. Researchers want to see if using the Floora device is safe and effective in reducing pelvic pain. To join, you must be a biological female between 18 and 80 years old with a diagnosis of IC/BPS and HTPFD, and a current pelvic pain score of 5 or higher. The study plans to enroll 10 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is testing the Floora Pelvic Rehabilitation Vaginal Dilator.
What's involved
You would use the Floora device at home at least three times per week for 12 weeks. You would also attend 3 in-person clinic visits and have two phone calls over a 16-week period.
Compensation
Not stated in the trial record.
Follow-up
Your pelvic pain score will be measured at baseline, week 6, and week 12.

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NCT07038512

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

Withdrawn
NAAges 18–80InterventionalSupportive care
Wake Forest University Health Sciences
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Floora Pelvic Rehabilitation Vaginal Dilator

At a glance

Recruiting sites

Site status isn't published for this study.

What they're measuring
Pelvic Pain Score
Measured over Baseline
+3 more outcomes measured

Conditions

Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Chronic
High Tone Pelvic Floor Dysfunction

Explore related trials

High-tone Pelvic Floor DysfunctionInterstitial Cystitis

Study leadership

  • Stephen J Walker, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest Institute for Regenerative Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pelvic Pain ScoreBaseline

    Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.

  • Pelvic Pain ScoreWeek 6

    Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.

  • Pelvic Pain ScoreWeek 12

    Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.

  • Pelvic Pain ScoreWeek 16

    Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.