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NCT07038512 · ClinicalTrials.gov registry record · NA
Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction
A NA study, sponsored by Wake Forest University Health Sciences.
- Not yet
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT07038512: Clinical Trial NA study, sponsored by Wake Forest University Health Sciences.
NCT07038512 is a NA study that has not yet begun recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07038512, a NA study, has not yet begun recruiting, sponsored by Wake Forest University Health Sciences.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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). 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.
Interventions
- DEVICE Floora Pelvic Rehabilitation Vaginal Dilator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-08 |
| Est. Completion | 2027-01 |
| Phase | NA |
What is known before NCT07038512 opens enrollment
NCT07038512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Floora Pelvic Rehabilitation Vaginal Dilator is the first listed.
NCT07038512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07038512 about?
NCT07038512 is a clinical study titled "Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/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...
What is the current status of trial NCT07038512?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2026-08. Estimated completion is 2027-01.
What interventions are being tested in trial NCT07038512?
The interventions under investigation include: Floora Pelvic Rehabilitation Vaginal Dilator (DEVICE).
Who is sponsoring clinical trial NCT07038512?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07038512's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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