Benign Prostatic Hyperplasia (BPH)
Conditions
Brief summary
The duration of the study is expected to take approximately 3 years, which includes a recruitment period of approximately 12-months and 2 years (24-months) to complete procedure and follow-up visits.
Detailed description
The study follow-up duration from the primary study procedure is 5 years. * Baseline * Study Procedure * 4-week * 6-month * 12-month * 24-month (End of Study) The study will be considered complete after all subjects have completed the 24-month follow-up visit.
Interventions
DEVICEGreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber
observational registry
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent and agrees to attend all study visits * Subject has a diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction * Subject is able to complete self-administered questionnaires * Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for the PVP procedure * Subject is ≥ 40 years of age * Subject has an IPSS score greater than or equal to 12 measured at the baseline visit * Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than or equal to 15ml/s and sample is greater than or equal to 150ml (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 150ml, and the Qmax is less than or equal to 15ml/s it may be used for the inclusion/
Exclusion criteria
) * Subject has medical record documentation of a prostate volume of greater than or equal to 30 grams by transrectal ultrasound (TRUS))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The GreenLight XPS system provides durable relief of BPH symptoms in subjects. | 6-month follow up | Changes of IPSS Scores in subjects treated with the GreenLight XPS Laser System at 6 months |
Countries
China
Outcome results
None listed