Ambulatory Long Length URodynamics Evaluation
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bright Uro
- Enrollment
- 101
- Locations
- 10
- Primary Endpoint
- Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
Overview
Brief Summary
A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.
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 provide a urine sample 7 days after sensor removal and will receive a follow-up phone call 14 days post-removal.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patient must be ≥ 22 years of age.
- •Patient is a candidate for UDS per standard of care.
- •Patient is able to provide informed consent.
Exclusion Criteria
- •Patient has one or more symptoms indicative of a 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 history of recurrent UTIs (≥ 3 episodes in previous 12 months).
- •Patient has used antibiotics within the past 7 days from the baseline/screening visit.
- •Patient diagnosed with neurogenic LUTD (i.e., one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).
- •Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).
- •Patient with a urostomy.
- •Patient with a colostomy.
- •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).
- •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).
- •Patient with any abnormal or concerning rectal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, or active yeast infections.
Arms & Interventions
Glean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Intervention: Glean Urodynamics System (Device)
Outcomes
Primary Outcomes
Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
Time Frame: From enrollment to 14 days after device removal
Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
Secondary Outcomes
No secondary outcomes reported