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Official title Ambulatory Long Length URodynamics Evaluation
ClinicalTrials.gov ID: NCT07425015
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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.
You likely can't join if
- Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic...
- 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...
- Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome...
- Patient with a urostomy.
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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.
- Patient has a known inability to void.
- Patient has a previous history of radiation leading to bleeding (e.g., hemorrhagic radiation cystitis).
- Patient is pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months, or intending to become pregnant during the study period.
- Patients who may not be able to independently use a smart device.
- people who, at the principal investigator's determination, would not be appropriate for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hanover, Maryland, United States
- Owings Mills, Maryland, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- West Columbia, South Carolina, United States
- Sioux Falls, South Dakota, United States
- Arlington, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanover, Maryland, United States; Owings Mills, Maryland, United States; St Louis, Missouri, United States; Cleveland, Ohio, United States; West Columbia, South Carolina, United States; Sioux Falls, South Dakota, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.