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

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

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

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

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

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.

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.

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 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.

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.

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.