Normal bladder function ranges with the Glean Urodynamics System in healthy adults

Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults

We will test the Glean Urodynamics System in healthy adults ages 18–45 to establish normal bladder monitoring measurements.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Bright Uro (industry)
• Locations: 3 sites (Phoenix, Arizona and 2 other locations)
• Trial ID: NCT07485205 on ClinicalTrials.gov

What this trial studies

This open‑label, single‑arm interventional protocol will insert the Glean Urodynamics System for in‑clinic ambulatory monitoring and then discharge participants with the bladder sensor in place for continued outpatient recording for up to 24 hours. The sensor will be removed within 24 hours and participants will receive a follow‑up phone call seven days later to check for any issues. The primary goal is to collect urodynamic measurements from healthy adults to define normative reference ranges for the device. Eligible volunteers are healthy men and women aged 18–45 who can consent, speak English, and operate a smart device, while those with prior pregnancy, current pregnancy, active urinary symptoms, or known urological disease are excluded.

Who should consider this trial

Good fit: Healthy adults aged 18–45 who can read and speak English, provide informed consent, have no history of urological disease or prior pregnancy, and can operate a smart device are the intended participants.

Not a fit: People who are older than 45, pregnant or with prior pregnancies, have current urinary symptoms or a history of urological conditions, or cannot use a smart device are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the study will provide clinicians with clear normal reference ranges for bladder pressure and activity measured by the Glean device, which could improve interpretation of urodynamic data and help future diagnosis and management.

How similar studies have performed: Ambulatory urodynamic monitoring and sensor‑based bladder measurements have been used in prior research to characterize bladder function, but using the specific Glean intravesical system to define normative ranges is relatively novel.

Eligibility criteria

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.

Where this trial is running

Phoenix, Arizona and 2 other locations

• Arizona Research Center — Phoenix, Arizona, United States (RECRUITING)
• Del Sol Research Management — Tucson, Arizona, United States (RECRUITING)
• Boulder Medical Center — Boulder, Colorado, United States (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Brittany Carter, DHSc, MPH

Conditions: Lower Urinary Tract Symptoms