Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction
Evaluation of the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator in Managing Interstitial Cystitis/ Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction
Sponsor: Hyivy Health Inc
Listed as NCT07038512, this observational or N/A phase trial focuses on High Tone Pelvic Floor Dysfunction and Interstitial Cystitis, Chronic and remains actively recruiting participants. Sponsored by Hyivy Health Inc, it has been updated 3 times since 2026, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)The expansion of Interstitial Cystitis (IC) to include Bladder Pain Syndrome (BPS) started in 2002 by the International Continence Society and was further expanded in 2008 to focus on the inclusion of chronic pelvic pain, pressure, and discomfort perceived to be related to the bladder. These symptoms must occur for more than 6 weeks in the absence of infection or other identifiable cause . There has been further distinction between patients who have erosive bladder lesions (Hunner lesions) and those who do not. The Floora allows women suffering from HTPFD and IC/BPS to manage their physical therapy treatment privately and comfortably in their own space, fostering a sense of control to take an active role in their healing. This self-controlled option can reduce anxiety, improve mental well-being, and increasing adherence to dilator therapy, ultimately leading to better outcomes in managing pain, thus improving quality of life for these patients.
The expansion of Interstitial Cystitis (IC) to include Bladder Pain Syndrome (BPS) started in 2002 by the International Continence Society and was further expanded in 2008 to focus on the inclusion of chronic pelvic pain, pressure, and discomfort perceived to be related to the bladder. These symptoms must occur for more than 6 weeks in the absence of infection or other identifiable cause . There has been further distinction between patients who have erosive bladder lesions (Hunner lesions) and those who do not. The Floora allows women suffering from HTPFD and IC/BPS to manage their physical therapy treatment privately and comfortably in their own space, fostering a sense of control to take an active role in their healing. This self-controlled option can reduce anxiety, improve mental well-being, and increasing adherence to dilator therapy, ultimately leading to better outcomes in managing pain, thus improving quality of life for these patients.
Status Flow
Change History
3 versions recorded-
Apr 28, 2026 — Present [daily]
Not Yet Recruiting
Phase: NA → None
-
Feb 2026 — Apr 2026 [monthly]
Not Yet Recruiting NA
-
Jul 2025 — Feb 2026 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility Summary
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.
Contact Information
- Hyivy Health Inc
- Wake Forest University Health Sciences
For direct contact, visit the study record on ClinicalTrials.gov .