No more catheters? new device aims to make bladder testing easier
NCT ID NCT05694793
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study is testing a new wireless device called the Glean Urodynamics System (GUS) that monitors bladder pressure without a catheter. It involves 28 adult women with urinary symptoms. Participants will use the device during standard tests and at home. The goal is to see if GUS is safe and reliable compared to traditional methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Glean Urodynamics System (GUS) - a wireless, catheter-free device for monitoring bladder pressure
- What this could lead to
- If successful, this could lead to a more comfortable and convenient way to diagnose bladder problems without the need for catheters.
- What could go wrong
- This is a small, early-stage trial with only 28 participants, so results may not apply to everyone. The device may not be as accurate as standard methods.
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.
- Participants
-
About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Jul 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- 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 Hide 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: 1. Female patient must be ≥ 18 years of age 2. Patient is a candidate for urodynamics per standard of care 3. Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: 1. Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period 2. Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria). 3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months). 4. Patient has used antibiotics within the past 7 days from the baseline/screening visit. 5. Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine). 6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS). 7. Patient with a urostomy. 8. Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall). 9. Patient who has from one or more major strictures in the urethra. 10. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen). 11. Patient with a colostomy. 12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis. 13. Patient has a known inability to void or is in complete retention. 14. Subjects who, at the principal investigator's determination, would not be appropriate for this study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Urodynamics are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic
Cleveland, Ohio, 44195, United States
-
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
-
University of California San Diego
San Diego, California, 92121, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Home urine tests may let men skip clinic visits for prostate symptoms
- Smart blood pressure monitoring may shield kidneys during robotic surgery
- Which laser frequency works best for prostate surgery?
- Water jet surgery: a new wave for prostate relief?
- Steam therapy for enlarged prostate: a new hope?
- A tiny dose of an old drug might stop Post-Surgery brain fog in seniors