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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Research Center
  Phoenix, Arizona, United States Recruiting
• Prestige Medical Group
  Tustin, California, United States Recruiting
• Del Sol Research Management
  Tucson, Arizona, United States Completed

Study contacts

• Study coordinator: Brittany Carter, DHSc, MPH
• Email: brittany@brighturo.com
• Phone: 949-202-5689

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.