Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction

CompletedOBSERVATIONAL
Enrollment

33

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

October 31, 2023

Study Completion Date

December 31, 2023

Conditions
Spinal Cord InjuriesUrinary Bladder, Neurogenic
Interventions
DEVICE

Cystometry

The procedure will be done according to the International Continence Society's (ICS) recommended indications for the procedure. The investigational device is inserted into a 12F single-use hydrophilic catheter. After correct positioning is verified by ultrasound and x-ray, the investigational device is released from the insertion catheter. The insertion catheter is then carefully removed, securing the correct positioning of the investigational device inside the bladder. The investigational device is connected to a data logger. In the conventional device, the intravesical pressure is recorded using a water perfused 3F catheter with a 3 ml/hour perfusion rate. The 3F catheter is hooked on an 8F catheter to facilitate introduction into the bladder. The catheters used for pressure transmission are connected to external transducers and a computer with software processing the recording

Trial Locations (1)

N-1450

Sunnaas Rehabilitation Hospital, Oslo

All Listed Sponsors
collaborator

SINTEF MiNaLab

UNKNOWN

collaborator

University of Oslo

OTHER

lead

Sunnaas Rehabilitation Hospital

OTHER