NXT Post-Market Clinical Follow-up

Launched by LABORIE MEDICAL TECHNOLOGIES INC. · Mar 21, 2024

Keywords

ClinConnect Summary

The NXT Post-Market Clinical Follow-up trial is studying the safety and effectiveness of the NXT Urodynamics System, which helps doctors understand how well the bladder and urinary system are working. This research specifically focuses on patients dealing with urinary issues, such as incontinence and bladder obstruction. The trial is currently recruiting participants of all ages and genders who need a urodynamic study, which is a test to assess bladder function.

To participate, individuals must be medically advised to undergo this study and provide consent for their involvement. However, some people may not be eligible, including those with active bladder infections, recent pelvic surgery, or certain cognitive conditions that might affect their ability to communicate about the study. Participants can expect to undergo tests related to their bladder function and will help researchers confirm that the NXT system continues to be safe and effective for patients. This research is important as it aims to improve the understanding of bladder health and treatment options for those experiencing urinary problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients medically indicated for urodynamic study
• • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Exclusion Criteria:
• • Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
• • Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
• • Pregnant women
• • Patients with recent (less than 2 weeks) pelvic floor surgery
• • Requires use of suprapubic catheter