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New device aims to define healthy bladder function
NCT ID NCT07485205
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study is testing a new device called the Glean Urodynamics System to measure bladder pressure in 72 healthy adults aged 18 to 45. The goal is to establish normal ranges for bladder function, which could help doctors better diagnose urinary issues in the future. Participants will use a small bladder sensor and other equipment to record pressure readings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could provide doctors with normal bladder pressure ranges, helping to better diagnose and treat urinary problems.
- What could go wrong
- This is an early-stage study with only 72 healthy participants, so results may not apply to everyone. It is not testing a treatment, only gathering data.
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
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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
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Healthy male and female adults ages 18 to 45 years. 2. Patient is able to read, write, and communicate in English. 3. Patient is able to provide informed consent. 4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes Exclusion Criteria: 1. Patient with any prior pregnancy (gravida ≥1), is currently pregnant (as confirmed by urine pregnancy test or medical history), or intends to become pregnant during the study period. 2. Patient has one or more symptoms indicative of a symptomatic 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 a known history of urological conditions (e.g., recurrent UTIs, incontinence, symptomatic benign prostatic hyperplasia, neurogenic bladder, interstitial cystitis, urinary retention, any genitourinary cancer). 4. Patient has a known history of neurological conditions that can affect central nervous system function. 5. Patients with a current or prior diagnosis of diabetes mellitus (Type 1 or Type 2). 6. Patient is currently taking medications that may affect urological functions (e.g., diuretics, anticholinergics, alpha-blockers). 7. Patient has abnormal urinary habits if one or more of the following bladder events are reported on any day of the 3-day bladder diary: urinary frequency ≥ 8 times/day, ≥ 1 nocturia episode, ≥ 1 leak event, or ≥ 1 urgency event. 8. Patient has a total score on the Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10) questionnaire greater than 0; a total score of 1 is acceptable only if the sole positive response is urinary frequency of 4-7 times per day. 9. Patient has a urostomy and/or colostomy. 10. 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) that the principal investigator deems might compromise the placement or retention of the Glean sensors during the study (e.g., strictures). 11. 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). 12. Patient would not be appropriate for this study as determined by the Principal Investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arizona Research Center
RECRUITINGPhoenix, Arizona, 85053, United States
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Del Sol Research Management
RECRUITINGTucson, Arizona, 85715, United States
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Prestige Medical Group
RECRUITINGTustin, California, 92780, United States
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