MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

BPH Clinical Trial

Official title:

MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131544
• Other study ID #: Prostate Laser Center BPH 01
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: May 15, 2020

Study information

• Verified date: April 2024
• Source: Prostate Laser Center, PLLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 15, 2020
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of lower urinary track symptoms (LUTS).

2. Prostate volume of 40 - 200 cc.

3. Men = 45 years old.

4. IPSS = 15.

5. BPH Impact Index = 5.

Exclusion Criteria:

1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.

2. Need to catheterize to relieve obstruction.

3. Daily use of incontinence materials/padding.

4. Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.

5. Prior interventional or surgical treatment of BPH.

6. Penile prosthesis.

7. Artificial urinary sphincter or collagen bladder injection.

8. Urethral stricture.

9. Bleeding disorder/coagulopathy.

10. Inability to refrain from blood thinners in the peri-procedural period.

11. Inability or chooses not to provide informed consent.

12. Any serious medical condition which would make proceeding to treatment unsafe.

13. Significant contraindication to MRI or gadolinium contrast.

14. Hip replacement.

15. Lack of a rectum.

16. Life expectancy of less than two years.

17. Unable or unwilling to complete all required questionnaires and follow-up assessments.

Related Conditions & MeSH terms

• BPH
• Hyperplasia
• Hypertrophy
• Prostate Hyperplasia
• Prostatic Hyperplasia
• Urinary Frequency/Urgency

Intervention

Device:
• MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.

Locations

Country	Name	City	State
United States	Prostate Laser Center, PLLC	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Prostate Laser Center, PLLC	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS) Change	The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).	From baseline to 2 months
Primary	International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")	From baseline to 2 months
Primary	BPH Impact Index Change	This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)	From baseline to 2 months
Primary	Sexual Health Inventory of Men (SHIM) Score Change	This survey rates erectile function from 0 (no function) to 25 (full function)	From baseline to 2 months
Primary	Number of Adverse Events	We asked patients to self-report adverse events.	Continuous until completion of the study at 2 years
Primary	International Prostate Symptom Score (IPSS) Change	The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).	From baseline to 4 months
Primary	International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")	From baseline to 4 months
Primary	BPH Impact Index Change	This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)	From baseline to 4 months
Primary	Sexual Health Inventory of Men (SHIM) Score Change	This survey rates erectile function from 0 (no function) to 25 (full function)	From baseline to 4 months
Primary	International Prostate Symptom Score (IPSS) Change	The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).	From baseline to 6 months
Primary	International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")	From baseline to 6 months
Primary	BPH Impact Index Change	This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)	From baseline to 6 months
Primary	Sexual Health Inventory of Men (SHIM) Score Change	This survey rates erectile function from 0 (no function) to 25 (full function)	From baseline to 6 months
Primary	International Prostate Symptom Score (IPSS) Change	The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).	From baseline to 24 months
Primary	International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")	From baseline to 24 months
Primary	BPH Impact Index Change	This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)	From baseline to 24 months
Primary	Sexual Health Inventory of Men (SHIM) Score Change	This survey rates erectile function from 0 (no function) to 25 (full function)	From baseline to 24 months

External Links

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