Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hypertrophy

Adenoma

Prostatic Hyperplasia

Hyperplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Pathological Conditions, Anatomical

Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.

The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Rezum System

Kevin M Hagelin

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.

Rezum I Pilot Study for Benign Prostatic Hyperplasia

NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure).

The device related complications that will be compared for this safety endpoint are:

1. Severe Urinary Retention (Retention ≥ 24 hours)
2. Fistula between rectum and urethra
3. Perforation of the rectum or GI tract
4. New incidences of retrograde ejaculation

The proportion of study subjects who were responders were evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS.

The proportion of study subjects who were responders were evaluated. For this measure a responder is defined as a subject with ≥ 50% improvement in BPH symptoms from baseline as measured by the IPSS.

Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months, 6 months, 1 year, annually to 5 years

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. Average results are based on age and sex. Typical uroflow rates ranges from 10 ml to 21 ml per second. An increase in mL/sec corresponds to improved urinary function.

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥ 30% improvement from baseline at each follow-up interval.

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥3 mL/sec improvement from baseline at each follow-up interval.

Change in post void residual (PVR) urine volume in ml. Post void residual volume was measured by either ultrasound to measure the volume left in the bladder after urination, or by inserting a urinary catheter into the bladder after urination to drain and measure residual urine. Either measurement tool was allowed but the same measurement was to be used pre and post treatment.

Change from baseline in sexual function was measured by the International Index of Erectile Function (IIEF) (Scoring on the IIEF ranges from 1 to 30. An increase in score indicates improvement from baseline)

Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.

Results report change in IPSS by follow up interval for subjects treated in both lateral lobes and median lobe vs. subjects treated in lateral lobes alone.

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval and grouped by Baseline IPSS. Improvement in symptoms is shown by a reduction in score.

Pain scores were obtained for all subjects using the Iowa Pain Thermometer. Maximum intraprocedural pain scores were analyzed, together with the pain scores reported at follow-up intervals through 3 months. The treatment pain scores were reported by subjects post-procedure and was based on their recollections. Scale is 0-12 with higher scores corresponding to higher pain reported.

Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit.

One question in the IPSS asked subjects to rate their "quality of life due to urinary symptoms" on a scale of 0 = Delighted to 6 = Terrible.

A reduction in score from baseline equates to improved outcome.

Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits.

BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.

Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. EQ-5D-3L index ranges from -0.109 to 1.000, with 1.000 corresponding to the best health state and -0.109 corresponding to the worst health. Mean change in overall score from baseline is reported.

Quality of Life was measured using EQ-5D-3L questionnaire and collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. The EQ-5D-3L includes a visual analog scale (VAS) which is a vertical scale with numbers ranging from 0 to 100. Subjects were asked to draw a line to the place on the scale that best represented how good or bad his health was on that day. The worst state a subject can imagine is marked zero, and the best state the subject can imagine is marked 100. Mean change in VAS score from baseline is reported. An increase in score is considered a better outcome.

Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. Each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension.

Presented below are the scoring counts for each of the dimensions for baseline and follow up interval.

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years.

These will be measured as:

• Proportion of subjects that are satisfied with the procedure overall

Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years.

Outcome measured as:

• Proportion of subjects that would recommend this treatment to friends and families

Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years.

Outcome measured as:

• Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years

Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Procedure time: Time from delivery device insertion to final delivery device withdrawal

Treatment time: time from first vapor delivery to last vapor delivery

Boston Scientific Corporation

Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Rezum Treatment

Age, Continuous

Sex: Female, Male

Ethnicity

Race/Ethnicity, Customized

Sweden

Czechia

Dominican Republic

Region of Enrollment

Consecutive subjects who met inclusion/exclusion criteria and consented to participate were enrolled and treated with the NxThera Rezūm System.

This was a pilot study conducted on a new therapy at a limited number of sites (3 total).

Director, Clinical Operations

IPSS Change at 1 Week

IPSS Change at 1 Month

IPSS Change at 3 Months

IPSS Change at 6 Months

IPSS Change at 12 Months

IPSS Change at 24 Months

IPSS Change at 36 Months

IPSS Change at 48 Months

IPSS Change at 60 Months

Mean change (improvement) in score was calculated for the number of subjects providing data at each follow-up visit.

International Prostate Symptom Score (IPSS) Change From Baseline

Severe urinary retention (retention >=24 hours

Fistula between rectum and urethra

Perforation of the Rectum or GI Tract

New incidences of retrograde ejaculation

Incidence of device-related complications pre-specified under this safety endpoint assessed through 3 months post-implant.

Major Complications

Proportion of Responders with>=30% Improvement at 1 Week

Proportion of Responders with>=30% Improvement at 1 Month

Proportion of Responders with>=30% Improvement at 3 Months

Proportion of Responders with>=30% Improvement at 6 Months

Proportion of Responders with>=30% Improvement at 12 Months

Proportion of Responders with>=30% Improvement at 24 Months

Proportion of Responders with>=30% Improvement at 36 Months

Proportion of Responders with>=30% Improvement at 48 Months

Proportion of Responders with>=30% Improvement at 60 Months

Subjects with data at baseline and at the follow-up visit are included in the data summarization.

Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement

Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Week

Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Month

Proportion of Responders with a ≥ 50% IPSS Improvement at 3 Months

Proportion of Responders with a ≥ 50% IPSS Improvement at 6 Months

Proportion of Responders with a ≥ 50% IPSS Improvement at 12 Months

Proportion of Responders with a ≥ 50% IPSS Improvement at 24 Months

Proportion of Responders with a ≥ 50% IPSS Improvement at 36 Months

Proportion of Responders with a ≥ 50% IPSS Improvement at 48 Months

Proportion of Responders with a ≥ 50% IPSS Improvement at 60 Months

Subjects with data at baseline and follow-up visits are included in the data summarization.

Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Week

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Month

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 3 Months

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 6 Months

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 12 Months

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 24 Months

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 36 Months

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 48 Months

Proportion of Responders With Improvement ≥ 8 Points in IPSS at 60 Months

Subjects with data at baseline and follow-up visit are included in the summarization.

Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS

Change from baseline in peak urinary flow rate (Qmax) at 1 Week

Change from baseline in peak urinary flow rate (Qmax) at 1 Month

Change from baseline in peak urinary flow rate (Qmax) at 3 Months

Change from baseline in peak urinary flow rate (Qmax) at 6 Months

Change from baseline in peak urinary flow rate (Qmax) at 12 Months

Change from baseline in peak urinary flow rate (Qmax) at 24 Months

Change from baseline in peak urinary flow rate (Qmax) at 36 Months

Change from baseline in peak urinary flow rate (Qmax) at 48 months

Change from baseline in peak urinary flow rate (Qmax) at 60 Months

Mean change in urinary flow rate was calculated for subjects with data at baseline and follow-up visit.

Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)

Qmax improvement of 30% or more over baseline at 1 Week

Qmax improvement of 30% or more over baseline at 1 Month

Qmax improvement of 30% or more over baseline at 3 Months

Qmax improvement of 30% or more over baseline at 6 Months

Qmax improvement of 30% or more over baseline at 12 Months

Qmax improvement of 30% or more over baseline at 24 Months

Qmax improvement of 30% or more over baseline at 36 Months

Qmax improvement of 30% or more over baseline at 48 months

Qmax improvement of 30% or more over baseline at 60 Months

Measure calculated for subjects with data at baseline and follow-up visit.

Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline

Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Week

Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Month

Subjects with Qmax Improvement of ≥ 3 ml/sec at 3 Months

Subjects with Qmax Improvement of ≥ 3 ml/sec at 6 Months

Subjects with Qmax Improvement of ≥ 3 ml/sec at 12 Months

Subjects with Qmax Improvement of ≥ 3 ml/sec at 24 Months

Subjects with Qmax Improvement of ≥ 3 ml/sec at 36 Months

Subjects with Qmax Improvement of ≥ 3 ml/sec at 48 months

Subjects with Qmax Improvement of ≥ 3 ml/sec at 60 Months

Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec

Change from baseline in PVR at 1 Week

Change from baseline in PVR at 1 Month

Change from baseline in PVR at 3 Months

Change from baseline in PVR at 6 Months

Change from baseline in PVR at 12 Months

Change from baseline in PVR at 24 Months

Change from baseline in PVR at 36 Months

Change from baseline in PVR at 48 months

Change from baseline in PVR at 60 Months

Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval

IEFF change from baseline at 1 Month

IEFF change from baseline at 3 Months

IEFF change from baseline at 6 Months

IEFF change from baseline at 12 Months

IEFF change from baseline at 24 Months

IEFF change from baseline at 36 Months

IEFF change from baseline at 48 Months

IEFF change from baseline at 60 Months

Mean change in total score was calculated for subjects providing data at each follow-up visit.

Change in Sexual Function - Erectile Function

Incidence of retrograde ejaculation at 1 Week

Incidence of retrograde ejaculation at 1 Month

Incidence of retrograde ejaculation at 3 Months

Change in Sexual Function - Retrograde Ejaculation

Rezum Treatment - Larger Prostates (≥35gm)

Rezum Treatment - Smaller Prostates (<35g)

Measure calculated for subjects providing data at each follow-up visit.

International Prostate Symptom Score (IPSS) Assessment by Prostate Volume

Rezum Treatment - No Median Lobe Present (Lateral Lobes Treated)

Rezum Treatment - Median Lobe Present (Lateral and Median Lobes Treated)

International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe

Subjects With Baseline IPSS 13-19

Subjects With Baseline IPSS 20-25

Subjects With Baseline IPSS 26-35

International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS

Pain Score on day of Treatment

Pain Score 1 Day Post-Treatment

Pain Score 1 Week Post-Treatment

Pain Score 1 Month Post-Treatment

Pain Score 3 Months Post-Treatment

Subjects with data at the scheduled visits are included in the data summarization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rezum I Pilot Study for Benign Prostatic Hyperplasia	NCT02943070	Prostatic Hyper... Benign Prostati... Adenoma, Prosta... Prostatic Adeno... Prostatic Hyper... Prostatic Hyper... Prostatic Hyper... Rezum	Rezum System	45 Years -	Boston Scientific Corporation
Rezum I Pilot Study for Benign Prostatic Hyperplasia	NCT02943070	Prostatic Hyper... Benign Prostati... Adenoma, Prosta... Prostatic Adeno... Prostatic Hyper... Prostatic Hyper... Prostatic Hyper... Rezum	Rezum System	45 Years -	Boston Scientific Corporation

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