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

WithdrawnNot applicableNCT07038512
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Evaluation of the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator in Managing Interstitial Cystitis/ Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction
Conditions
  • Interstitial Cystitis/Painful Bladder Syndrome
  • Interstitial Cystitis, Chronic
  • High Tone Pelvic Floor Dysfunction
Interventions
  • Device: Floora Pelvic Rehabilitation Vaginal Dilator
Sponsor
Wake Forest University Health Sciences
Collaborators
Hyivy Health Inc
Start date
2026-08
Primary completion
2026-12
Sex
Female
Age range
from 18 Years to 80 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 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 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07038512