Spinal Cord Injuries Clinical Trial
— PEPRE2Official title:
Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
NCT number | NCT06445426 |
Other study ID # | SUPRE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | December 31, 2023 |
Verified date | June 2024 |
Source | Sunnaas Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Sunnaas Rehabilitation Hospital | Oslo | Nesoddtangen |
Lead Sponsor | Collaborator |
---|---|
Sunnaas Rehabilitation Hospital | SINTEF MiNaLab, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Advert effects monitoring and resolution | Subjects will be examined for any subjective or objective adverse events. The transurethral technique is well-known, and the complication rates are very low. However, there are known complications such as urinary tract infection, hematuria, pain, retention, and autonomic dysreflexia in tetraplegics. Subjects will be routinely examined for all these conditions, and if any of them occur, adequate treatment will be initiated according to hospital guidelines. The small-sized sensor tube (Ø ˜ 1.2 mm) provides a minimally invasive clinical procedure. In case of perforation, the lesion will be small. | 72 hours | |
Primary | 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 |
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