The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.
Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
Subject is willing and able to complete all follow-up visits
Subject is ≥ 40 years of age
Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
Subject requires simultaneous surgical treatment for BPH
Unwilling or unable to provide consent
Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
The SALT study will enroll subjects undergoing a diagnostic or therapeutic urinary tract procedure, or benign prostatic hyperplasia (BPH) procedure, using study devices. Subjects will generally be recruited from Investigators' practices. A minimum of 119 subjects will be enrolled in each cohort.
Cohort
Prospective
Ureteroscope system
DeviceLithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Laser system
DevicePulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Occurrence of Serious Adverse Events related to BSC study devices
The primary endpoint is the occurrence of serious adverse events related to BSC study devices.
Assess Stone Free Rate in therapeutic Urinary Tract Procedures
For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study.
Change in BPH symptoms
In subjects with applicable benign prostatic hyperplasia (BPH) procedure(s): Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 6 months follow up, on a scale of 0 to 35.
Health status as measured by EQ-5D-5L
Pre-and post-operative health status as measured by a validated quality-of-life questionnaire, the EQ-5D five-level (5L) (EQ-5D-5L). The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) to rate perceived health from 0 (worst imaginable health) to 100 (best imaginable health).
Pre- and post-operative pain assessment in Urinary Tract Procedure Cohort
Pre- and post-operative pain as measured by validated pain questionnaire (Brief Pain Inventory).
Change in uroflowmetry in BPH cohort
Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) within 12 months of index procedure
Quality of Life for BPH cohort measured by Male Sexual Health Questionnaire (MSHQ)
Quality of Life for BPH cohort measured via a validated questionnaire, Male Sexual Health Questionnaire (MSHQ). Change in MHSQ score will be assessed. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.
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