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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Floora Pelvic Rehabilitation Vaginal Dilator — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Intervention
  Participants will be instructed to use the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator at least three times per week for a total of 12-weeks. Each session consists of 10 minutes of heat and 10 minutes of dilation.

Primary Outcome Measure

Pelvic Pain Score [ Time Frame: Baseline ]

Central Contacts

• Kaylee Ferrara, MA
  336-713-1693
  [email protected]

Locations (1)

Find similar trials in Winston-Salem, NC

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