N/A
Completed N=10
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
BPH · Prostate Hyperplasia · Urinary Frequency/Urgency
Source: ClinicalTrials.gov NCT03131544 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: International Prostate Symptom Score (IPSS) Change — -17.5 units on a scale
Summary
Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Prostate Symptom Score (IPSS) Change |
-20.1 | — |
| PRIMARY International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change |
-3.7 | — |
| PRIMARY BPH Impact Index Change |
-7.7 | — |
| PRIMARY Sexual Health Inventory of Men (SHIM) Score Change |
2.8 | — |
| PRIMARY Number of Adverse Events |
4 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of lower urinary track symptoms (LUTS).
- Prostate volume of 40 - 200 cc.
- Men ≥ 45 years old.
- IPSS ≥ 15.
- BPH Impact Index ≥ 5.
Exclusion Criteria
- History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
- Need to catheterize to relieve obstruction.
- Daily use of incontinence materials/padding.
- Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
- Prior interventional or surgical treatment of BPH.
- Penile prosthesis.
- Artificial urinary sphincter or collagen bladder injection.
- Urethral stricture.
- Bleeding disorder/coagulopathy.
- Inability to refrain from blood thinners in the peri-procedural period.
- Inability or chooses not to provide informed consent.
- Any serious medical condition which would make proceeding to treatment unsafe.
- Significant contraindication to MRI or gadolinium contrast.
- Hip replacement.
- Lack of a rectum.
- Life expectancy of less than two years.
- Unable or unwilling to complete all required questionnaires and follow-up assessments.
Data sourced from ClinicalTrials.gov (NCT03131544). 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.