In Vivo Comparison of Air Charged Catheters with Water Filled Catheters for Intravesical and Intrarectal Pressures Recording during Urodynamic Testing.

Completed

• Conditions: lower urinary tract dysfunction; urinary incontinence; voiding dysfunction; 10046590

• Registration Number: NL-OMON39662
• Lead Sponsor: T-doc-LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

2 sets of criteria follow: for 'all female' and for all persons with neurogenid dysfunction.;Female >18 years
Scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and symptoms of lower urinary tract dysfunction.
*May perform (not excluded) intermittent (self) catheterisation.
No signs of voiding dysfunction (routine outpatient max flow >20mL/s without significant (>100mL)postvoid residual)
No signs of bladder /pelvic pain syndrome;OR:
Male or female >18years
Complete spinal cord injury, level above T12, or meningomyelocele unable to void and significantly reduced or no pelvic floor, urethral and or bladder sensation.
* May have (not excluded) *sacral sparing*; some residual anal sensation
Scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and symptoms of lower urinary tract dysfunction or because of routine (protocol, guidelines) follow -up.
* (Usually: performing intermittent (self) catheterisation); not excluded.
* May have (not excluded) chronic indwelling catheter.

Exclusion Criteria

One (or more) of the following necessitates exclusion of the patient:;Male with normal lower urinary tract sensation.;Unwilling or unfit to sign informed consent.
ASA >2; Karnovski <80%.;Women with voiding dysfunction
Patients included in other scientific studies (for other reasons).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: Difference of intravesical pressure increment<br /><br>maximum during filling cystometry between the two systems.</p><br>