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.
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
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.)
Single group
Floora Pelvic Rehabilitation Vaginal Dilator
DeviceThe 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.
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.
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.
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.
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.
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.
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.
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.
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.
Hyivy Device Satisfaction Questionnaire
The Hyivy Device Satisfaction questionnaire was created by Hyivy Health Inc to gather feedback from users. It assesses the user's overall opinion of the devices usability, functionality, performance and how well it meets their needs.
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Wake Forest University Health Sciences
Lead sponsor
Hyivy Health Inc
Collaborator
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