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

Bright Uro

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms (LUTS)

Treatments: Device: Glean Urodynamics System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07485205

CIP-0018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Glean Urodynamics System

Experimental group

Description:

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

Treatment:

Device: Glean Urodynamics System