Interstitial Cystitis/Painful Bladder SyndromeNCT07038512
Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction
A study testing Floora Pelvic Rehabilitation Vaginal Dilator in people with Interstitial Cystitis/Painful Bladder Syndrome and Interstitial Cystitis, Chronic, run by Wake Forest University Health Sciences.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Interstitial Cystitis/Painful Bladder Syndrome, Interstitial Cystitis, Chronic, High Tone Pelvic Floor Dysfunction
- What is being tested?
- Floora Pelvic Rehabilitation Vaginal Dilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: Evaluation of the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator in Managing Interstitial Cystitis/ Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction
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.
Read the detailed description
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.
- Conditions
- Interstitial Cystitis/Painful Bladder Syndrome, Interstitial Cystitis, Chronic, High Tone Pelvic Floor Dysfunction
- Being tested
- Floora Pelvic Rehabilitation Vaginal Dilator
- Keywords
- bladder and pelvic pain, lower urinary tract symptoms, sexual function
- Medical subject headings
- Cystitis, Interstitial, Pelvic Pain, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floora Pelvic Rehabilitation Vaginal DilatorDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Floora Pelvic Rehabilitation Vaginal Dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 16
Secondary outcomes (5)
O'Leary-Sant Interstitial cystitis (IC) Symptom Score
The O'Leary Sant Instrument has two parts: the ICSI assesses the presence and severity of common IC/BPS symptoms, and the ICPI assesses how these symptoms are perceived by the patient, or how big of a "problem" they are perceived to be. Both components consist of 4 questions, with responses to ICSI questions ranging from 0 (not at all) to 5 (almost always) and responses to ICPI questions ranging from 0 (no problem) to 4 (big problem). A total score (ICSI+ICPI) of greater than 12 strongly suggests the diagnosis of IC/BPS, with higher numerical scores indicating increased severity of disease.
Measured: Baseline, 6-weeks, 12-weeks and 16-weeks
Pelvic Pain, Urgency and Frequency (PUF) Questionnaire Score
The PUF patient symptom scale is a validated instrument used to assess the severity of symptoms associated with pelvic pain conditions, like IC/BPS, and the degree to which these symptoms "bother" a patient. It is separated into two subsections, the symptom score and the bother score, to produce one composite score. The symptom score is comprised of seven items addressing urinary frequency, urgency, nocturia, dyspareunia, and pelvic pain. The bother score consists of four items assessing the degree to which the evaluable symptoms trouble the patient. Each question is scored from 0 (never) to 3 (always) or 1 (mild) to 3 (severe), except for two which quantify daytime frequency and nocturia separately with scores ranging from 0 to 4. A composite score between 10 and 14 indicates a strong diagnosis of IC/BPS with higher scores reflecting a greater degree of severity of symptoms and disease progression as well as impact on quality of life.
Measured: Baseline, 6-weeks, 12-weeks and 16-weeks
Pelvic Floor Impact Questionnaire- Short Form 7 (PFIQ-7)
The PFIQ-7 is a shortened version of the Pelvic Floor Impact Questionnaire (PFIQ). It is a health-related quality of life questionnaire for women with pelvic floor conditions. It consists of seven questions that need to answered three times each, and assesses symptoms related to the bladder/urine, vagina/pelvis, and bowel/rectum and their effect on function, social health, and mental health in the past 3 months. The responses for each question range from 0 (not at all) to 3 (quite a bit). To get scale scores, the mean of each of the three scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and divided by 3. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score indicates a lesser effect on quality of life.
Measured: Baseline, 6-weeks, 12-weeks and 16-weeks
The Female Sexual Functioning Index (FSFI)
The FSFI is a 19-item multidimensional self-reporting measure that quantifies female sexual dysfunction in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores for the arousal, lubrication, orgasm, and pain domains range from 0 to 6 using Likert-type scales. Scores for desire range from 1.2 to 6.0, and those for satisfaction range from 0.8 to 6.0. The total score is the sum of the domain scores and ranges from 2 to 36, and the recall period is the past 4 weeks. Higher scores indicate a better level of sexual function.
Measured: Baseline, 6-weeks, 12-weeks and 16-weeks.
The Global Response Assessment (GRA)
The GRA will be performed post-treatment to evaluate how ultimately effective this treatment is from the perspective of the participants. It is structed on a 7-point Likert scale centered at 0, indicating no change. The question is asked as follows: "As compared to when you started the current study, how would you rate your overall symptoms now?". Participants will rate their symptoms as: Markedly worse, Moderately worse Slightly worse, The same, Slightly improved, moderately improved and markedly improved.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Study has been withdrawn due to ongoing difficulties with device manufacturing and our inability to reach the sponsor team for updates or guidance over the recent period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Cystitis/Painful Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hyivy Health Inc
- Responsible party
- Sponsor
- Investigators
- Stephen J Walker, PhD, Principal investigator, Wake Forest Institute for Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038512
- Sponsor's protocol ID
- IRB00130697
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator in Managing Interstitial Cystitis/ Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT07038512
- Acronym / sponsor ID
- IRB00130697
- Conditions
- Interstitial Cystitis/Painful Bladder Syndrome, Interstitial Cystitis, Chronic, High Tone Pelvic Floor Dysfunction
- Keywords
- bladder and pelvic pain, lower urinary tract symptoms, sexual function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been withdrawn due to ongoing difficulties with device manufacturing and our inability to reach the sponsor team for updates or guidance over the recent period.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Hyivy Health Inc
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Floora Pelvic Rehabilitation Vaginal DilatorParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floora Pelvic Rehabilitation Vaginal DilatorThe 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. | Device | Intervention |
Primary outcome
Pelvic Pain Score
Time frame: Baseline
Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.
Pelvic Pain Score
Time frame: Week 6
Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.
Pelvic Pain Score
Time frame: Week 12
Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.
Pelvic Pain Score
Time frame: Week 16
Overall pelvic pain score, measured on an 11-point Likert scale with 0 meaning no pain and 10 meaning the worst pain imaginable.
5 secondary outcomes
O'Leary-Sant Interstitial cystitis (IC) Symptom Score
Time frame: Baseline, 6-weeks, 12-weeks and 16-weeks
Pelvic Pain, Urgency and Frequency (PUF) Questionnaire Score
Time frame: Baseline, 6-weeks, 12-weeks and 16-weeks
Pelvic Floor Impact Questionnaire- Short Form 7 (PFIQ-7)
Time frame: Baseline, 6-weeks, 12-weeks and 16-weeks
The Female Sexual Functioning Index (FSFI)
Time frame: Baseline, 6-weeks, 12-weeks and 16-weeks.
The Global Response Assessment (GRA)
Time frame: 12-weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Hyivy Health Inc WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Walker, PhD principal investigator
Wake Forest Institute for Regenerative Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Floora Pelvic Rehabilitation Vaginal Dilator in people with Interstitial Cystitis/Painful Bladder Syndrome and Interstitial Cystitis, Chronic, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Pain Score (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.