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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBright Uro

About this trial

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.

Eligibility criteria

Qualifiers

Healthy male and female adults ages 18 to 45 years.

Patient is able to read, write, and communicate in English.

Patient is able to provide informed consent.

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

Disqualifiers

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.

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).

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).

Patient has a known history of neurological conditions that can affect central nervous system function.

Trial design

Treatments tested in this trial

  • Glean Urodynamics System

Treatment groups

72 Participants
are divided into 1 treatment group

Sponsors and collaborators