Floora Pelvic Rehabilitation for Interstitial Cystitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Floora Pelvic Rehabilitation Vaginal Dilator for women with interstitial cystitis (a painful bladder condition) and high-tone pelvic floor dysfunction (muscle problems causing pelvic pain). The study aims to determine if this device, which uses heat and gentle stretching, can safely and effectively reduce pain and improve bladder symptoms. Participants will use the device at home three times a week for 12 weeks and attend a few clinic visits. Women diagnosed with these conditions and experiencing significant pelvic pain might be suitable for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to pioneering research that could lead to new treatment options.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot start any new treatments for your condition during the 12-week study period.
What prior data suggests that the Floora Pelvic Rehabilitation Vaginal Dilator is safe for females with Interstitial Cystitis?
Research shows that the Floora Pelvic Rehabilitation Vaginal Dilator is undergoing safety testing in women with Interstitial Cystitis (a painful bladder condition) and High-tone Pelvic Floor Dysfunction (tight pelvic muscles). Detailed information about side effects for this specific device is limited in the provided sources. The trial phase is listed as "Not Applicable," indicating early testing stages. Early-stage studies typically focus on ensuring safety before progressing to larger trials. If the device were already approved for other uses, some safety data would be available, but this is not mentioned here. Therefore, participants should be aware that safety data is still being collected and reviewed.12345
Why are researchers excited about this trial?
Most treatments for interstitial cystitis, like oral medications and bladder instillations, aim to manage symptoms and reduce inflammation. However, the Floora Pelvic Rehabilitation Vaginal Dilator introduces a unique approach by combining heat therapy with dilation exercises. This dual-action method not only helps relax pelvic muscles but also potentially enhances blood flow and tissue healing in the pelvic area. Researchers are excited about this treatment because it offers a non-invasive, at-home therapy option that could provide relief without the side effects commonly associated with traditional medications.
What evidence suggests that the Floora Pelvic Rehabilitation Vaginal Dilator is effective for Interstitial Cystitis?
Research has shown that pelvic floor physical therapy (PFPT) with intravaginal myofascial release can effectively treat pelvic pain and related symptoms. In this trial, participants will use the Floora Pelvic Rehabilitation Vaginal Dilator, which enhances PFPT by applying heat and gentle stretching to potentially relax tight pelvic muscles. Although specific data on the Floora device remains limited, similar treatments have proven beneficial for conditions like painful bladder syndrome and high-tone pelvic floor dysfunction. Early findings suggest that heat and stretching could reduce pain and improve function for those affected. However, specific data for the Floora device is still being gathered.12678
Who Is on the Research Team?
Stephen Walker, PhD
Principal Investigator
Wake Forest Institute for Regenerative Medicine
Are You a Good Fit for This Trial?
This trial is for females with conditions like Interstitial Cystitis, Pelvic Floor Hypertonicity, and related bladder pain syndromes. Participants should use the Floora device three times a week at home for 12 weeks and attend three clinic visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator at least three times per week for 12 weeks, with each session consisting of 10 minutes of heat and 10 minutes of dilation.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including pelvic pain score and various questionnaires.
What Are the Treatments Tested in This Trial?
Interventions
- Floora Pelvic Rehabilitation Vaginal Dilator
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Hyivy Health Inc
Industry Sponsor