|- candidate number||28497|
|- NTR Number||NTR7009|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jan-2018|
|- Secondary IDs||P14.257 // NL50168.058.14 CME nummer // NL nummer|
|- Public Title||Validatie van meting met enkele urethrale druksensor in het aantonen van drukvariaties in de urethra tijdens vullings cystometrie|
|- Scientific Title||Validation of single urethral sensor catheter in demonstrating urethral pressure variations during filling cystometry|
|- hypothesis||To validate the use of single urethral sensor catheter in demonstrating urethral pressure variations during filling cystometry
|- Healt Condition(s) or Problem(s) studied||LUTS (Lower Urinary Tract Symptoms)|
|- Inclusion criteria||Every female patient scheduled for urodynamic evaluation |
|- Exclusion criteria||none|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2016|
|- planned closingdate||31-dec-2018|
|- Target number of participants||75|
|- Interventions||Removal of three-sensor catheter and introduction of a single-sensor catheter for the second measurement series during urodynamic evaluation|
|- Primary outcome||Primary endpoint is the reproduction of urethral pressure variations, demonstrated with three-sensor catheter, with use of a single-sensor catheter during filling cystometry.
|- Secondary outcome||n.a.|
|- Timepoints||one timepoint, the day/date of urodynamic evaluation |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.T.M. Kummeling|
|- CONTACT for SCIENTIFIC QUERIES||Drs J.I.M. van Uhm|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Astellas Pharma B.V, Astellas Research Grant|
|- Brief summary||Rationale: During the filling (urine storage) phase of a urodynamic investigation (= investigation to measure bladder function or dysfunction, which explains the pathophysiology of the symptoms), urethral (bladder outlet) pressure variations can be observed in a proportion of patients. The clinical relevance and or the role of urethral pressure variations in the pathophysiology are yet not precisely established. |
In the literature, urethral pressure variations have been discussed with the use of a catheter with single sensor or three sensors in the urethra. However, there are very few hospitals using a multiple-sensor urethral catheter. In the gross majority, a catheter with only one sensor in the urethra is used. If clinical relevance of urethral pressure variations is to be further examined, the demonstrating of this condition has to be more widely applicable.
Objective: To validate the use of single urethral sensor catheter in demonstrating urethral pressure variations during filling cystometry
Study design: Prospective observational intervention study.
Study population: Adult female patients, mentally fit to consent, undergoing urodynamic evaluation.
Intervention: Removal of three-sensor catheter and introduction of a single-sensor catheter for the second measurement series during urodynamic evaluation.
Main study parameters/endpoints: Primary endpoint is the reproduction of urethral pressure variations, demonstrated with three-sensor catheter, with use of a single-sensor catheter during filling cystometry.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During urodynamic testing usually two series of filling and voiding cystometry are performed, to be able to reproduce and measure burden symptoms of the patient. To validate the use of a single-sensor catheter, the three-sensor catheter has to be removed after the first series and an extra introduction of the single-sensor urethral catheter has to be performed.
|- Main changes (audit trail)|
|- RECORD||25-jan-2018 - 13-feb-2018|