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Could a smart vaginal wand ease bladder pain without drugs?

NCT ID NCT07038512

Symptom relief Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests a new at-home device called the Floora Pelvic Rehabilitation Vaginal Dilator in 10 women with interstitial cystitis (painful bladder syndrome) and high-tone pelvic floor dysfunction. Participants use the device three times a week for 12 weeks, combining heat and gentle dilation. The goal is to see if it safely reduces pelvic pain and improves symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Floora Pelvic Rehabilitation Vaginal Dilator (device)
What this could lead to
If it works, this could offer a safe, at-home option for women to manage chronic pelvic pain without medication or clinic visits.
What could go wrong
This is a very small early trial with only 10 participants, no comparison group, and no blinding, so results may not apply widely. The device is new and its long-term benefits or risks are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

interstitial cystitis Lower Urinary Tract Symptoms Pelvic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High tone pelvic floor dysfunction Interstitial cystitis, chronic Interstitial cystitis/painful bladder syndrome

More trials for these conditions

Other studies related to the condition(s) this trial covers.