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

Wake Forest University (WFU)

Status: Begins enrollment in 2 months

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

Treatments: Device: Floora Pelvic Rehabilitation Vaginal Dilator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07038512

IRB00130697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Device: Floora Pelvic Rehabilitation Vaginal Dilator