Air-charged vs Water-filled Catheters (Bonn)

NCT02756182 | Completed Results

• 1 other identifier: AvW-Bonn-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at various fill volumes for the bladder.

Conditions

Urodynamics

Outcome Measures

Primary Outcomes (3)

• Maximum Vesical Pressure During Valsalva Manoeuvres

  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.

  Measured during a single urodynamic evaluation

• Maximum Abdominal Pressure During Valsalva Manoeuvres

  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.

  Measured during a single urodynamic evaluation

• Maximum Detrusor Pressure at Valsalva Manoeuvres

  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.

  Measured during a single urodynamic evaluation

Secondary Outcomes (3)

• Maximum Vesical Pressure During Coughs

  Measured during a single urodynamic evaluation

• Maximum Abdominal Pressure During Coughs

  Measured during a single urodynamic evaluation

• Maximum Detrusor Pressure During Coughs

  Measured during a single urodynamic evaluation

Study Arms (1)

Urodynamics with AC and WP

EXPERIMENTAL

Patients underwent a conventional urodynamics study utilizing a single catheter technique

Device: TDOC air-charged catheter

Interventions

TDOC air-charged catheter DEVICE

Urodynamic study utilizing a single catheter technique to measure WP \& AC measurements

Urodynamics with AC and WP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients normally indicated for urodynamic evaluations

You may not qualify if:

• Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
• Patients who suffer from strictures in the urethra
• Patients who are pregnant
• Patients who require the use of a suprapubic catheter

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (1)

University Clinic Bonn

Bonn, 53177, Germany

Location

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Laborie

sgallone@laborie.com

9056121170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 29, 2016
• Study Start: April 27, 2016
• Primary Completion: August 22, 2016
• Study Completion: August 22, 2016
• Last Updated: January 31, 2020
• Results First Posted: September 19, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)