Normal bladder and urethral pressure ranges measured with e-Sense catheters
e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
This project will test e-Sense catheters to define normal urodynamic pressure values in adults referred for urodynamic testing, with enrollment focused on people aged 20–35 (women nulliparous) and those over 50 (women with at least one vaginal birth).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Laborie Medical Technologies Inc. Industry-sponsored |
| Locations | 1 site (Bristol) |
| Trial ID | NCT06905808 on ClinicalTrials.gov |
What this trial studies
This is a post‑market observational effort enrolling adults referred for clinic urodynamics to collect pressure data using both e-Sense electronic catheters and standard water‑filled catheters. Resting pressures will be recorded in lying, sitting, and standing positions and pressure values will be measured at intervals during bladder filling. Detrusor and urethral pressures captured by the e-Sense device will be compared to the water‑filled catheter values to define expected normal ranges. The resulting reference values will be provided to clinicians and the device sponsor to support interpretation of e-Sense measurements.
Who should consider this trial
Good fit: Ideal candidates are adults referred for urodynamic testing who are aged 20–35 (women must be nulliparous) or older than 50 (women must have had at least one vaginal birth), able to give informed consent and without excluded conditions.
Not a fit: Patients who are pregnant, have active untreated bladder infections, anal/rectal symptoms or surgery, cognitive impairment preventing consent, or a post-void residual over 300 mL are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide clinicians with device-specific reference ranges that improve interpretation of urodynamic results obtained with e-Sense catheters.
How similar studies have performed: Standard water‑filled catheter urodynamics are well established, but defining device-specific normal ranges for single‑sensor electronic catheters like e-Sense is relatively novel with limited published comparative data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects medically indicated for Urodynamic procedure between ages 20-35 or \> 50 years old (equally split male and female) * Due to aging and giving birth significantly affecting the urethra: * Female subjects 20-35 should be nulliparous. * Female subjects \> 50 years old should have given birth to at least one child vaginally. Further caesarian births would not mean exclusion from the study. * Subjects with range of BMI values * Subject provides written authorization and/or consent per institution or geographical requirements Exclusion Criteria: * Subjects with cognitive or psychiatric conditions that interfere with or precludes direct and accurate communication regarding the study, giving informed consent * Any anal / rectal symptoms and/or surgery * Pregnant women * Subjects with active untreated bladder infections (not including patients with asymptomatic bacteruria) * Subjects having greater than 300 mL post void residual on the clinic visit uroflowmetry test
Where this trial is running
Bristol
- Bristol Urological Institute — Bristol, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.