N/A
Completed N=956
GreenLight XPS Laser System Retrospective Chart Review
Source: ClinicalTrials.gov NCT02139969 ↗Enrolled (actual)
956
Serious AEs
1.4%
Results posted
Nov 2020
Primary outcomePrimary: International Prostate Symptom Score (IPSS) — 437; 118; 17 Participants
Summary
The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Prostate Symptom Score (IPSS) |
437; 118; 17 | — |
| PRIMARY Occurrence of Adverse Events Related to the Study Treatment. |
249 | — |
| SECONDARY Characteristics of the Study Procedure |
57.1; 33.2 | — |
| SECONDARY Characteristics of the Study Procedure and Immediate Outcomes |
1.2 | — |
| SECONDARY Assess Changes in Quality of Life Related to BPH Symptoms. |
1.3 | — |
| SECONDARY Assess Changes in Objective Measures of Urologic Function. |
4.9; 2.6; -2.0 | — |
| SECONDARY Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure |
39; 43; 14; 19; 4 | — |
| SECONDARY Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence |
0.9; 0.9; 1.3; 1.1 | — |
| SECONDARY Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. |
4; 3 | — |
| SECONDARY Characteristics of the Study Procedure and Immediate Outcomes |
1.2 | — |
| SECONDARY Length of Hospital Stay |
0.5 | — |
| SECONDARY Type of Hospital Stay |
674; 222; 58 | — |
| SECONDARY Number of Participants Stratified by Number of Fibers Used During Procedure |
873; 76; 4 | — |
| SECONDARY Assess Changes in Objective Measures of Urologic Function |
204.3; 46.1; -172 | — |
| SECONDARY Changes in Objective Measures of Urologic Function |
76.0; 44.0; -31.8 | — |
| SECONDARY Assess Changes in Objective Measures of Urologic Function. |
4.9; 2.6; -2.0 | — |
Eligibility Criteria
Inclusion Criteria
- Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.
Exclusion Criteria
- Subject has had prior radiation.
- Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC))
- Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded)
- Subject has an artificial urinary sphincter
Data sourced from ClinicalTrials.gov (NCT02139969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.