Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (Rezūm XL)

• ClinicalTrials.gov Identifier: NCT03605745
• Recruitment Status: Terminated
• First Posted: July 30, 2018
• Results First Posted: August 10, 2021
• Last Update Posted: August 10, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: BPH With Urinary Obstruction; BPH; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Intervention: Device: Prostatic Vapor Ablation
• Enrollment: 47

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment
Arm/Group Description	Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Period Title: Overall Study
Started	47
2 Weeks	47
6 Weeks	47
3 Months	47
6 Months	47
12 Months	40
24 Months	1
Completed	0
Not Completed	47
Reason Not Completed
Study was terminated for business reasons	47

Baseline Characteristics

Arm/Group Title		Treatment
Arm/Group Description		Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Number of Baseline Participants		47
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	47 participants
		67.8 (6.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	47 participants
	Female	0 0.0%
	Male	47 100.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	47 participants
	Hispanic or Latino	4 8.5%
	Not Hispanic or Latino	43 91.5%
	Unknown or Not Reported	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	47 participants
Black or African American		3 6.4%
American Indian or Alaska Native		0 0.0%
Asian		0 0.0%
Native Hawaiian or Other Pacific Islander		0 0.0%
White		40 85.1%
Hispanic or Latino		4 8.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	47 participants
		47

Outcome Measures

1. Primary Outcome

Title	Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
Description	The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) > 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All subjects enrolled were included in the analysis.

Arm/Group Title	Treatment
Arm/Group Description:	Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Number of Participants Analyzed	47
Measure Type: Count of Participants; Unit of Measure: Participants
	39 83.0%

2. Primary Outcome

Title	Number of Participants With Post Procedure Device Related Serious Complications
Description	Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All subjects enrolled were included in the analysis.

Arm/Group Title	Treatment
Arm/Group Description:	Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Number of Participants Analyzed	47
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

3. Secondary Outcome

Title	Number of Subjects With Device-related Retention Catheterizations
Description	This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Time Frame	6 Month

Outcome Measure Data

Analysis Population Description

All subjects enrolled were included in the analysis.

Arm/Group Title	Treatment
Arm/Group Description:	Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Number of Participants Analyzed	47
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

4. Secondary Outcome

Title	Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
Description	The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time Frame	Baseline, 6 weeks, 3 months, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

All subjects with data at both baseline and the follow-up visit were included in the analysis (N=47 at 6 weeks, 3 months, 6 months; N=42 at 12 months).

Arm/Group Title		Treatment
Arm/Group Description:		Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Overall Number of Participants Analyzed		47
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Change from baseline to 6 weeks post-therapy	Number Analyzed	47 participants
		-8.47; (-10.49 to -6.45)
Change from baseline to 3 months post-therapy	Number Analyzed	47 participants
		-10.97; (-12.68 to -9.27)
Change from baseline to 6 months post-therapy	Number Analyzed	47 participants
		-11.62; (-13.43 to -9.80)
Change from baseline to 12 months post-therapy	Number Analyzed	42 participants
		-11.80; (-13.57 to -10.03)

Adverse Events

Time Frame	Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit.
Adverse Event Reporting Description	For all adverse events related to the device, the procedure, or the disease state being treated, a Clinical Events Committee was utilized for review and adjudication.
Arm/Group Title	Treatment
Arm/Group Description	Prostatic Vapor Ablation with Rezum Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
All-Cause Mortality
	Treatment
	Affected / at Risk (%)
Total	0/47 (0.00%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	4/47 (8.51%)
Gastrointestinal disorders
Inguinal Hernia † [1]	1/47 (2.13%)	1
Infections and infestations
Acute Prostatitis † [2]	1/47 (2.13%)	1
Nervous system disorders
Bells Palsy †	1/47 (2.13%)	1
Renal and urinary disorders
Hematuria Gross with Clots & Retention †	1/47 (2.13%)	1
† Indicates events were collected by systematic assessment; [1] Worsening of Right Inguinal Hernia; [2] Acute Prostatitis
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment
	Affected / at Risk (%)	# Events
Total	41/47 (87.23%)
Gastrointestinal disorders
Constipation †	3/47 (6.38%)	3
Pain/Discomfort - Abdominal †	1/47 (2.13%)	1
General disorders
Pain/Discomfort - Other †	4/47 (8.51%)	5
Fever †	2/47 (4.26%)	2
Sloughing †	2/47 (4.26%)	2
Infections and infestations
UTI - Culture Proven †	11/47 (23.40%)	13
Epididymitis †	2/47 (4.26%)	2
Nervous system disorders
Headache †	1/47 (2.13%)	1
Product Issues
Catheter Malfunction †	1/47 (2.13%)	1
Renal and urinary disorders
Hematuria - Gross †	12/47 (25.53%)	12
Urinary Urgency †	10/47 (21.28%)	11
Bladder Spasms †	10/47 (21.28%)	10
Dysuria †	10/47 (21.28%)	10
Acute Urinary Retention †	7/47 (14.89%)	7
Urinary Incontinence - Urge †	5/47 (10.64%)	6
Poor Stream †	5/47 (10.64%)	5
Terminal Dribbling †	4/47 (8.51%)	4
Urinary Incontinence - Not Specified †	3/47 (6.38%)	4
Nocturia †	3/47 (6.38%)	3
Hesitancy †	2/47 (4.26%)	2
Incomplete Voiding †	2/47 (4.26%)	2
Urinary Frequency †	2/47 (4.26%)	2
Hematuria - Intermittent Uncomplicated †	1/47 (2.13%)	1
Hematuria Gross with Clots & Retention †	1/47 (2.13%)	1
Reproductive system and breast disorders
Pain/Discomfort - Penile †	4/47 (8.51%)	5
Erectile Dysfunction - Worsening †	3/47 (6.38%)	3
Anejaculation †	2/47 (4.26%)	2
Decrease in Ejaculatory Volume †	2/47 (4.26%)	2
Hematospermia †	2/47 (4.26%)	2
Erectile Dysfunction - De Novo †	1/47 (2.13%)	1
Pain/Discomfort - Pelvic †	1/47 (2.13%)	1
Pain/Discomfort - Suprapubic †	1/47 (2.13%)	1
Retrograde Ejaculation - Confirmed †	1/47 (2.13%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

The study was terminated by the sponsor for business reasons. As a result there is no patient data presented for the 12 month, 2 year and 3 year follow up visits as they did not occur per termination.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kaitlyn Rainbow, Clinical Research Associate
• Organization: Boston Scientific
• Phone: 952-930-6627
• EMail: kat.rainbow@bsci.com

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03605745
• Other Study ID Numbers: 3034-001
• First Submitted: July 23, 2018
• First Posted: July 30, 2018
• Results First Submitted: June 4, 2021
• Results First Posted: August 10, 2021
• Last Update Posted: August 10, 2021