Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/16/2018 |
| Start Date: | December 2011 |
| End Date: | October 10, 2016 |
An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
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.
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.
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 < 15mL/sec
- Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
- Prostate volume ≥ 30g
Exclusion Criteria:
- PVR > 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
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