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

NCT06445426 | Completed DMC

• 1 other identifier: SUPRE
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the feasibility and safety of a novel system for percutaneous measurement of bladder pressure. This system enables minimally invasive procedures and high-quality recordings, offering a sampling rate and synchronization surpassing traditional methods. The pressure sensor system has the potential to be developed into a low-cost method suitable for mass production. The study will include a sample of convenience of up to 40 subjects. Pressure will be recorded simultaneously in the bladder using both the conventional and novel pressure recording systems. This simultaneous recording method will provide a direct comparison of pressure recordings between the two systems. Subjects will be examined for any subjective or objective adverse events.

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Keywords

Urodynamics

Outcome Measures

Primary Outcomes (1)

• Bladder pressure

  The bladder pressure recorded simultaneously by a conventional clinical system and the prototype will be used for a systemstic comparison analysis in the time-amplitude and the time-frequency domains.

  24 hours

Other Outcomes (1)

• Advert effects monitoring and resolution

  72 hours

Study Arms (1)

Simulataneous bladder pressure recording

In all patients recruited, the pressure will be recorded simultaneously with the conventional and novel pressure recording systems in the bladder. The procedure will be done according to the International Continence Society's (ICS) recommended indications for the procedure.

Device: Cystometry

Interventions

Cystometry DEVICE

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

Also known as: Pressure measurement in the urinary bladder

Simulataneous bladder pressure recording

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from patients with chronic spinal cord injury (SCI) admitted for cystometry at Sunnaas Hospital´s urodynamic laboratory. All subjects will have a clinical indication for cystometry.

You may qualify if:

• Documented traumatic or non-traumatic spinal cord injury
• Documented neurogenic bladder dysfunction by previous cystometry
• More than 3 months after injury
• Subject is able to communicate in Norwegian
• Subject is able and willing to sign informed consent
• Subject is able to complete all study requirements

You may not qualify if:

• History or evidence of previous urological or lower abdominal abnormalities from disease or surgery
• Use of anti-platelet or anti-coagulant other than low molecular weight heparin or acetylsalicylic acid which cannot be discontinued
• Symptomatic urinary tract infection
• Hemophilia or other clotting disorders that cause bleeding diathesis
• Any condition or situation, which, in the investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• SINTEF MiNaLab: collaborator
• University of Oslo: collaborator

Study Sites (1)

Sunnaas Rehabilitation Hospital

Oslo, Nesoddtangen, N-1450, Norway

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: June 6, 2024
• Study Start: June 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)