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

NCT07038512 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB00130697
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

bladder and pelvic pain; lower urinary tract symptoms; sexual function

Outcome Measures

Primary Outcomes (4)

• Pelvic Pain Score

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

  Baseline

• Pelvic Pain Score

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

  Week 6

• Pelvic Pain Score

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

  Week 12

• Pelvic Pain Score

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

  Week 16

Secondary Outcomes (5)

• O'Leary-Sant Interstitial cystitis (IC) Symptom Score

  Baseline, 6-weeks, 12-weeks and 16-weeks

• Pelvic Pain, Urgency and Frequency (PUF) Questionnaire Score

  Baseline, 6-weeks, 12-weeks and 16-weeks

• Pelvic Floor Impact Questionnaire- Short Form 7 (PFIQ-7)

  Baseline, 6-weeks, 12-weeks and 16-weeks

• The Female Sexual Functioning Index (FSFI)

  Baseline, 6-weeks, 12-weeks and 16-weeks.

• The Global Response Assessment (GRA)

  12-weeks

Other Outcomes (1)

• Hyivy Device Satisfaction Questionnaire

  12-weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Device: Floora Pelvic Rehabilitation Vaginal Dilator

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Hyivy Health Inc: collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist Urology

Winston-Salem, North Carolina, 27103, United States

Location

Related Links

• Hyivy Health Inc Website

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urological Manifestations

Study Officials

• Stephen J Walker, PhD

  Wake Forest Institute for Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylee Ferrara, MA

CONTACT

336-713-1693; kaylee.ferrara@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective single-arm proof-of-concept before-after trial evaluating pain relief following a 12-week trial of the Floora Pelvic Rehabilitation Vaginal Dilator in female's with high-tone pelvic floor dysfunction and Interstitial Cystitis/Bladder Pain Syndrome.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 26, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)