Recruiting

Urodynamics System

Sponsor:

Bright Uro

Code:

NCT07485205

Conditions

Lower Urinary Tract Symptoms (LUTS)

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Glean Urodynamics System

Study Details

Brief 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.

Conditions

Lower Urinary Tract Symptoms (LUTS)

Study ID

NCT07485205

Start date

Mar 31, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Glean Urodynamics System

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

Interventions

Glean Urodynamics System

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

Primary outcome measure

  • Range of vesical pressure (Pves) [ Time Frame: Periprocedurally ]

Central Contacts and Locations

Central contacts

Brittany Carter, DHSc, MPH

949-202-5689brittany@brighturo.com

Suranjan Roychowdhury, PhD

949-202-5685suranjan@brighturo.com

Locations

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Principal Investigator:

Cameron Meek, MD

Del Sol Research Management

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Wendy Hotz, R.Ph.

whots@delsolresearch.com

Principal Investigator:

Susan Kalota, MD

Prestige Medical Group

Recruiting

Tustin, California, United States, 92780

Contacts

Principal Investigator:

Lamia Gabal, MD

More Information

Sponsor

Bright Uro

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bright Uro on 2026-07-27.