MedTrace Logo

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

NCT07038512 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Floora Pelvic Rehabilitation Vaginal Dilator

The Floora Pelvic Rehabilitation Vaginal Dilator, created by Hyivy Health Inc, is a multi-therapy hand held ergonomic intravaginal wand device that is designed to be used in the comfort of the user's home. The Floora has two main therapeutic functions, controllable dilation and thermal therapy. It is the first vaginal dilator that performs auto-dilation using one or two air chambers inflated from the device surface by an internal pump, eliminating the need for reinsertion. The device is equipped with biosensors that measure the pressure from the vaginal canal which allows this device to provide a gradual and gentle stretch to the pelvic floor muscles. The thermal therapy is achieved through an electrical circuit, changing the temperature of the device in small increments. Users are able to force-stop and change the temperature and dilation settings during a session.

Sponsors & Collaborators

  • Hyivy Health Inc

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038512 on ClinicalTrials.gov