Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) (REZUM)

• ClinicalTrials.gov Identifier: NCT01912339
• Recruitment Status: Completed
• First Posted: July 31, 2013
• Results First Posted: May 15, 2017
• Last Update Posted: April 13, 2020
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptom
• Interventions: Device: Rezum System; Procedure: Rigid Cystoscopy
• Enrollment: 197

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment	Control	Crossover of Control Subjects
Arm/Group Description	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.	Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
Period Title: Blinded (0 to 3 Months)
Started	136	61	0
Completed	134	61	0
Not Completed	2	0	0
Reason Not Completed
Declined to participate	1	0	0
Open Prostatectomy	1	0	0
Period Title: Unblinded (3 to 6 Months/Crossover)
Started	134	61	0
Completed	133 [1]	61 [2]	0 [1]
Not Completed	1	0	0
Reason Not Completed
Withdrawal by Subject	1	0	0
[1] Still in study; [2] Of the 61 subjects, there were 53 crossover subjects and 8 that completed their study participation.
Period Title: Unblinded (6 Months/Crossover to 5 Yrs)
Started	133	0 [1]	53 [2]
Completed	0	0	0
Not Completed	133	0	53
Reason Not Completed
Lost to Follow-up	5	0	0
Missed Visit	5	0	0
Withdrawal by Subject	1	0	3
BPH Medication	1	0	0
TURP/Laser	1	0	0
Physician Decision	0	0	1
Death	0	0	1
Subject started on Cialis	0	0	1
Had PVP - Prostate laser surgery	0	0	1
Still in Study	120	0	46
[1] All subjects for the control group either completed study or crossed over.; [2] Control subjects that have crossed over.

Baseline Characteristics

Arm/Group Title		Treatment	Control	Total
Arm/Group Description		Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.	Total of all reporting groups
Overall Number of Baseline Participants		136	61	197
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	136 participants	61 participants	197 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	84 61.8%	36 59.0%	120 60.9%
	>=65 years	52 38.2%	25 41.0%	77 39.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	136 participants	61 participants	197 participants
		63.0 (7.1)	62.9 (7.0)	62.9 (7.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	136 participants	61 participants	197 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	136 100.0%	61 100.0%	197 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	136 participants	61 participants	197 participants
		136	61	197

Outcome Measures

1. Primary Outcome

Title	Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up
Description	Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).
Time Frame	3 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

Intention to Treat population (ITT)

Arm/Group Title	Treatment	Control
Arm/Group Description:	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Overall Number of Participants Analyzed	136	61
Mean (95% Confidence Interval); Unit of Measure: Cange in IPSS score
	-11.2; (-12.5 to -9.9)	-4.3; (-6.1 to -2.5)

2. Primary Outcome

Title	Safety: Device Related Serious Complications
Description	This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months. Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat population (ITT) for treatment arm subjects only. Control subjects did not undergo a treatment procedure so they were not assessed for this endpoint.

Arm/Group Title	Treatment	Control
Arm/Group Description:	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Overall Number of Participants Analyzed	136	0
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Participants
	1; (0 to 4.6)

3. Secondary Outcome

Title	Responders at 3 Months
Description	Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat population (ITT)

Arm/Group Title	Treatment	Control
Arm/Group Description:	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Overall Number of Participants Analyzed	136	61
Measure Type: Number; Unit of Measure: Participants
	106	21

4. Secondary Outcome

Title	Responders at 6 Months
Description	Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.

Arm/Group Title	Treatment	Control
Arm/Group Description:	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Overall Number of Participants Analyzed	136	0
Measure Type: Number; Unit of Measure: Participants
	102

5. Secondary Outcome

Title	Responders at 12 Months
Description	Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.

Arm/Group Title	Treatment	Control
Arm/Group Description:	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.	Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Overall Number of Participants Analyzed	136	0
Measure Type: Number; Unit of Measure: Participants
	104

Adverse Events

Time Frame	1 year,10 months
Adverse Event Reporting Description	Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Arm/Group Title	Treatment		Control
Arm/Group Description	Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum 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, your body will absorb the treated tissue through its natural healing response.		Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
All-Cause Mortality
	Treatment		Control
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/136 (13.24%)		4/61 (6.56%)
Gastrointestinal disorders
Bowel Obstruction † [1]	2/136 (1.47%)	3	0/61 (0.00%)	0
General disorders
Nausea † [2]	1/136 (0.74%)	1	0/61 (0.00%)	0
Vomiting † [2]	1/136 (0.74%)	1	0/61 (0.00%)	0
Syncope † [1]	1/136 (0.74%)	1	1/61 (1.64%)	1
Infections and infestations
Infection (other than UTI) † [1]	1/136 (0.74%)	1	1/61 (1.64%)	1
Musculoskeletal and connective tissue disorders
Injury, other (fractured ribs) † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Other, Broken Right Thumb † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, other † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Nervous system disorders
Spinal Stenosis † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Renal and urinary disorders
Urinary Retention † [2]	1/136 (0.74%)	1	0/61 (0.00%)	0
UTI, Culture Proven † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Pyelonephritis † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia † [1]	2/136 (1.47%)	2	2/61 (3.28%)	2
Pulmonary Embolus † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Vascular disorders
Hemorrhoids † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
Other - Atherosclerotic Artery Disease † [1]	1/136 (0.74%)	1	0/61 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] Not related to procedure; [2] Related to procedure
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/136 (48.53%)		4/61 (6.56%)
Renal and urinary disorders
Dysuria †	23/136 (16.91%)	24	1/61 (1.64%)	1
Hematuria, Gross †	17/136 (12.50%)	17	0/61 (0.00%)	0
Urinary, Frequency †	9/136 (6.62%)	9	2/61 (3.28%)	2
Urinary Urgency †	8/136 (5.88%)	8	1/61 (1.64%)	1
Reproductive system and breast disorders
Hematospermia †	10/136 (7.35%)	10	0/61 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

All adverse events reported, including those not related to the Rezum procedure. Events related to the procedure are summarized in McVary 2016 (see "Publications automatically indexed to this study").

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: Kevin Hagelin, Clinical Program Manager
• Organization: Boston Scientific Corporation
• Phone: (800) 328-3881
• EMail: kevin.hagelin@bsci.com

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01912339
• Other Study ID Numbers: 2105-001
• First Submitted: July 26, 2013
• First Posted: July 31, 2013
• Results First Submitted: November 29, 2016
• Results First Posted: May 15, 2017
• Last Update Posted: April 13, 2020