Phase 4 Completed N=66 Randomized Treatment

Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH)

Source: ClinicalTrials.gov NCT01500057 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcomePrimary: Change From Baseline in American Urological Association Symptom Score — -14.7; -10.5 units on a scale

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in American Urological Association Symptom Score	-14.7; -10.5	—
PRIMARY Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)	5.9; 2.3	—
SECONDARY Change From Baseline to 12 Months in Post Void Residual Volume	-61.9; -36.7	—

Eligibility Criteria

Inclusion Criteria

male over the age of 18 years
present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
subjects must read, understand and sign the Informed Consent
AUA ≥ 15
Qmax 300ml
Current urine retention
Previous surgical or invasive treatments (TURP, TUMT, TUNA)
PSA ≥ 4 (must have negative biopsy within last 12 months)
Neurogenic bladder
Obstruction due to urethral stricture
Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01500057). 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.