ClinicalTrials.gg
RecruitingNCT07485205Updated Nov 4, 2026

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

An interventional study of Glean Urodynamics System in Lower Urinary Tract Symptoms (LUTS), sponsored by Bright Uro. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Bright Uro · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Updated Nov 4, 2026Site recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.

Read the detailed description

Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period. Afterward, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will receive a follow-up phone call 7 days post-removal.

02

Conditions studied

  • Lower Urinary Tract Symptoms (LUTS)
03

In context

Lower Urinary Tract Symptoms

416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's planned enrollment of 72 is below the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

Bright Uro is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Glean Urodynamics System

    Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

    Device: Glean Urodynamics System

Interventions

  • DeviceGlean Urodynamics System

    Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

06

What researchers measure

Primary outcomes

  1. Range of vesical pressure (Pves)

    Range of vesical pressure (Pves) in cm H2O as measured by the Glean Bladder Sensor

    Time frame: Periprocedurally

07

Study locations

2 of 3 sites recruiting
  • Arizona Research Center
    Phoenix, Arizona 85053, United States
    Recruiting
    • Cameron Meek, MD · Principal investigator
    • Daniel Jaffee, MD · Sub investigator
  • Del Sol Research Management
    Tucson, Arizona 85715, United States
    Completed

    Not enrolling at this site.

  • Prestige Medical Group
    Tustin, California 92780, United States
    Recruiting
08

References and documents

Publications

  • Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2. PubMed 40314068 ↗

Individual participant data

Plan to share: No — Proprietary data

09

Updates

1 registry update since Sep 25, 2026
Sites
Del Sol Research Management is now Completed
Nov 4, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Del Sol Research Management · Tucson, United StatesContact removed w•••@delsolresearch.comContact removed (no phone or email listed)
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Del Sol Research Management is now Completed
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Del Sol Research Management · Tucson, United StatesContact removed w•••@delsolresearch.comContact removed (no phone or email listed)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07485205
Lead sponsor
Bright Uro
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Mar 31, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Brittany Carter, DHSc, MPH
Contact
brittany@brighturo.com
949-202-5689
Suranjan Roychowdhury, PhD
Contact
suranjan@brighturo.com
949-202-5685
Brittany Carter
study director · Bright Uro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion