Trial Outcomes & Findings for Air-charged vs Water-filled Catheters (Bonn) (NCT NCT02756182)

NCT ID: NCT02756182

Last Updated: 2020-01-31

Results Overview

Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Measured during a single urodynamic evaluation

Results posted on

2020-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Urodynamics With Air-Charged and Water Perfused Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure Water Perfused (WP) \& Air-Charged (AC) measurements
Overall Study STARTED	25
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Urodynamics With Air-Charged and Water Perfused Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure Water Perfused (WP) \& Air-Charged (AC) measurements
Overall Study StudyTechnical Difficulties	4

Baseline Characteristics

Air-charged vs Water-filled Catheters (Bonn)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Urodynamics With AC and WP n=25 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WP \& AC measurements
Age, Continuous	43.3 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Germany	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured during a single urodynamic evaluation

Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Outcome measures

Outcome measures
Measure	Urodynamics With AFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements	Urodynamics With WFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements
Maximum Vesical Pressure During Valsalva Manoeuvres	39.31 cmH2O Standard Deviation 23.02	39.44 cmH2O Standard Deviation 23.34

PRIMARY outcome

Timeframe: Measured during a single urodynamic evaluation

Maximum abdominal pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Outcome measures

Outcome measures
Measure	Urodynamics With AFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements	Urodynamics With WFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements
Maximum Abdominal Pressure During Valsalva Manoeuvres	37.93 cmH2O Standard Deviation 21.70	38.11 cmH2O Standard Deviation 22.04

PRIMARY outcome

Timeframe: Measured during a single urodynamic evaluation

Maximum detrusor pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Outcome measures

Outcome measures
Measure	Urodynamics With AFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements	Urodynamics With WFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements
Maximum Detrusor Pressure at Valsalva Manoeuvres	1.72 cmH2O Standard Deviation 3.85	1.65 cmH2O Standard Deviation 3.39

SECONDARY outcome

Timeframe: Measured during a single urodynamic evaluation

Maximum vesical pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Outcome measures

Outcome measures
Measure	Urodynamics With AFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements	Urodynamics With WFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements
Maximum Vesical Pressure During Coughs	64.59 cmH2O Standard Deviation 39.21	69.65 cmH2O Standard Deviation 43.25

SECONDARY outcome

Timeframe: Measured during a single urodynamic evaluation

Maximum abdominal pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Outcome measures

Outcome measures
Measure	Urodynamics With AFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements	Urodynamics With WFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements
Maximum Abdominal Pressure During Coughs	60.71 cmH2O Standard Deviation 35.66	63.01 cmH2O Standard Deviation 38.67

SECONDARY outcome

Timeframe: Measured during a single urodynamic evaluation

Maximum detrusor pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.

Outcome measures

Outcome measures
Measure	Urodynamics With AFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure AFC measurements	Urodynamics With WFC n=21 Participants Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WFC measurements
Maximum Detrusor Pressure During Coughs	3.89 cmH2O Standard Deviation 9.44	6.83 cmH2O Standard Deviation 7.82

Adverse Events

Urodynamics With AC and WP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Urodynamics With AC and WP n=25 participants at risk Patients underwent a conventional urodynamics study utilizing a single catheter technique TDOC air-charged catheter: Urodynamic study utilizing a single catheter technique to measure WP \& AC measurements
Blood and lymphatic system disorders High blood pressure with autonomic dysreflexia	4.0% 1/25 • Number of events 1

Additional Information

Clinical Research Manager

Laborie

Phone: 9056121170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place