An interventional study of Rezum System in Prostatic Hyperplasia, Benign Prostatic Hyperplasia and Adenoma, Prostatic, sponsored by Boston Scientific Corporation. Completed at 3 sites in 3 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 50 is below the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Use of concomitant medications to include the following:
Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.
Device: 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.
Also known as: Rezum Procedure, Rezum, Water Vapor Ablation, Rezum Delivery Device, Rezum Generator
International Prostate Symptom Score (IPSS) Change From Baseline
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Major Complications
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
Time frame: 3 months
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Proportion of Responders - Responders With Improvement ≥ 8 Points in 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
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Uroflow Assessment - Change in Post Void Residual (PVR) by 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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Change in Sexual Function - Erectile Function
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)
Time frame: 1 month, 3 months, 6 months, 1 year, annually to 5 years
Change in Sexual Function - Retrograde Ejaculation
Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)
Time frame: 1 Week post procedure, 1 Month post procedure, 3 Months post procedure
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Procedural Pain 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.
Time frame: Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)
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.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)
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.
Time frame: Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L
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.
Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)
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.
Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L
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.
Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
Subject Satisfaction - Satisfied With Overall Procedure
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.
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family
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.
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years
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.
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
Procedural Parameters - Procedure Time
Procedure time: Time from delivery device insertion to final delivery device withdrawal
Time frame: Day of Procedure
Procedural Parameters - Treatment Time
Treatment time: time from first vapor delivery to last vapor delivery
Time frame: Day of Procedure
This prospective, international, multicenter, non-randomized study recruited subjects who met inclusion/exclusion criteria and consented to participate. Subjects on BPH medication underwent a washout period prior to treatment. Subjects who successfully completed the washout period and still met the inclusion/exclusion criteria were enrolled in the study. Subjects were considered officially enrolled only if treatment with the NxThera Rezūm System was attempted.
| Milestone | Rezum Treatment |
|---|---|
| Started | 50 |
| Completed | 7 |
| Not completed | 43 |
| Withdrew: Physician decision | 1 |
| Withdrew: Adverse event | 2 |
| Withdrew: Death | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Retreatment or turp | 13 |
| Withdrew: Subjects exited after their 48 month visit per the sponsor's decision to close the study. | 18 |
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.
| score on a scale | Rezum Treatment |
|---|---|
| IPSS Change at 1 Week | -0.4 ± 7.8 |
| IPSS Change at 1 Month | -5.0 ± 8.3 |
| IPSS Change at 3 Months | -13.1 ± 7.2 |
| IPSS Change at 6 Months | -12.6 ± 7.9 |
| IPSS Change at 12 Months | -12.2 ± 7.7 |
| IPSS Change at 24 Months | -11.7 ± 8.4 |
| IPSS Change at 36 Months | -9.4 ± 9.0 |
| IPSS Change at 48 Months | -9.6 ± 7.5 |
| IPSS Change at 60 Months | -8.4 ± 6.7 |
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
| clinically relevant complications | Rezum Treatment |
|---|---|
| Severe urinary retention (retention >=24 hours | 1 |
| Fistula between rectum and urethra | 0 |
| Perforation of the Rectum or GI Tract | 0 |
| New incidences of retrograde ejaculation | 0 |
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.
| Participants | Rezum Treatment |
|---|---|
| Proportion of Responders with>=30% Improvement at 1 Week | 12 |
| Proportion of Responders with>=30% Improvement at 1 Month | 20 |
| Proportion of Responders with>=30% Improvement at 3 Months | 39 |
| Proportion of Responders with>=30% Improvement at 6 Months | 40 |
| Proportion of Responders with>=30% Improvement at 12 Months | 36 |
| Proportion of Responders with>=30% Improvement at 24 Months | 28 |
| Proportion of Responders with>=30% Improvement at 36 Months | 19 |
| Proportion of Responders with>=30% Improvement at 48 Months | 18 |
| Proportion of Responders with>=30% Improvement at 60 Months | 4 |
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.
| Participants | Rezum Treatment |
|---|---|
| Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Week | 3 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Month | 14 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 3 Months | 35 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 6 Months | 35 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 12 Months | 30 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 24 Months | 20 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 36 Months | 15 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 48 Months | 13 |
| Proportion of Responders with a ≥ 50% IPSS Improvement at 60 Months | 2 |
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
| Participants | Rezum Treatment |
|---|---|
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Week | 9 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Month | 18 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 3 Months | 37 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 6 Months | 37 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 12 Months | 33 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 24 Months | 24 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 36 Months | 17 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 48 Months | 16 |
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 60 Months | 4 |
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.
| mL/sec | Rezum Treatment |
|---|---|
| Change from baseline in peak urinary flow rate (Qmax) at 1 Week | -0.2 ± 4.3 |
| Change from baseline in peak urinary flow rate (Qmax) at 1 Month | 1.9 ± 4.8 |
| Change from baseline in peak urinary flow rate (Qmax) at 3 Months | 5.5 ± 6.6 |
| Change from baseline in peak urinary flow rate (Qmax) at 6 Months | 5.2 ± 5.7 |
| Change from baseline in peak urinary flow rate (Qmax) at 12 Months | 4.7 ± 7.0 |
| Change from baseline in peak urinary flow rate (Qmax) at 24 Months | 4.1 ± 6.7 |
| Change from baseline in peak urinary flow rate (Qmax) at 36 Months | 3.5 ± 6.2 |
| Change from baseline in peak urinary flow rate (Qmax) at 48 months | 3.0 ± 4.3 |
| Change from baseline in peak urinary flow rate (Qmax) at 60 Months | 3.9 ± 4.3 |
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.
| Participants | Rezum Treatment |
|---|---|
| Qmax improvement of 30% or more over baseline at 1 Week | 14 |
| Qmax improvement of 30% or more over baseline at 1 Month | 21 |
| Qmax improvement of 30% or more over baseline at 3 Months | 28 |
| Qmax improvement of 30% or more over baseline at 6 Months | 32 |
| Qmax improvement of 30% or more over baseline at 12 Months | 30 |
| Qmax improvement of 30% or more over baseline at 24 Months | 20 |
| Qmax improvement of 30% or more over baseline at 36 Months | 13 |
| Qmax improvement of 30% or more over baseline at 48 months | 4 |
| Qmax improvement of 30% or more over baseline at 60 Months | 4 |
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.
| Participants | Rezum Treatment |
|---|---|
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Week | 11 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Month | 19 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 3 Months | 30 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 6 Months | 30 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 12 Months | 27 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 24 Months | 18 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 36 Months | 12 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 48 months | 3 |
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 60 Months | 3 |
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.
| ml | Rezum Treatment |
|---|---|
| Change from baseline in PVR at 1 Week | 48.8 ± 135.9 |
| Change from baseline in PVR at 1 Month | -20.2 ± 94.7 |
| Change from baseline in PVR at 3 Months | -30.5 ± 72.4 |
| Change from baseline in PVR at 6 Months | -27.1 ± 81.6 |
| Change from baseline in PVR at 12 Months | -22.8 ± 83.7 |
| Change from baseline in PVR at 24 Months | -11.8 ± 102.2 |
| Change from baseline in PVR at 36 Months | 11.9 ± 134.4 |
| Change from baseline in PVR at 48 months | -14.3 ± 54.5 |
| Change from baseline in PVR at 60 Months | -12.6 ± 52.4 |
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)
| score on a scale | Rezum Treatment |
|---|---|
| IEFF change from baseline at 1 Month | -4.2 ± 20.7 |
| IEFF change from baseline at 3 Months | 3.3 ± 20.0 |
| IEFF change from baseline at 6 Months | 6.3 ± 17.6 |
| IEFF change from baseline at 12 Months | 5.8 ± 16.4 |
| IEFF change from baseline at 24 Months | 8.2 ± 14.8 |
| IEFF change from baseline at 36 Months | 10.7 ± 16.9 |
| IEFF change from baseline at 48 Months | 2.7 ± 27.4 |
| IEFF change from baseline at 60 Months | 12.5 ± 24.1 |
Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)
| Participants | Rezum Treatment |
|---|---|
| Incidence of retrograde ejaculation at 1 Week | 0 |
| Incidence of retrograde ejaculation at 1 Month | 0 |
| Incidence of retrograde ejaculation at 3 Months | 0 |
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.
| score on a scale | Rezum Treatment - Larger Prostates (≥35gm) | Rezum Treatment - Smaller Prostates (<35g) |
|---|---|---|
| IPSS Change at 1 Week | 0.3 ± 7.2 | -2.4 ± 9.3 |
| IPSS Change at 1 Month | -3.4 ± 8.0 | -9.4 ± 7.8 |
| IPSS Change at 3 Months | -12.0 ± 6.6 | -15.9 ± 8.3 |
| IPSS Change at 6 Months | -11.8 ± 7.1 | -14.9 ± 9.7 |
| IPSS Change at 12 Months | -11.6 ± 7.7 | -13.7 ± 8.0 |
| IPSS Change at 24 Months | -10.2 ± 8.4 | -16.1 ± 7.4 |
| IPSS Change at 36 Months | -9.2 ± 9.3 | 10.0 ± 8.8 |
| IPSS Change at 48 Months | -9.6 ± 8.4 | -9.5 ± 4.0 |
| IPSS Change at 60 Months | -6.0 ± 5.6 | -14.5 ± 6.4 |
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.
| score on a scale | Rezum Treatment - No Median Lobe Present (Lateral Lobes Treated) | Rezum Treatment - Median Lobe Present (Lateral and Median Lobes Treated) |
|---|---|---|
| IPSS Change at 1 Week | 0.4 ± 7.6 | -2.5 ± 8.2 |
| IPSS Change at 1 Month | -4.1 ± 7.0 | -7.4 ± 11.2 |
| IPSS Change at 3 Months | -11.9 ± 6.7 | -17.0 ± 7.8 |
| IPSS Change at 6 Months | -12.2 ± 7.5 | -14.3 ± 9.2 |
| IPSS Change at 12 Months | -11.9 ± 7.5 | -13.1 ± 8.7 |
| IPSS Change at 24 Months | 11.7 ± 7.7 | -11.8 ± 10.9 |
| IPSS Change at 36 Months | -9.4 ± 8.9 | -9.2 ± 10.2 |
| IPSS Change at 48 Months | -10.5 ± 7.4 | -5.6 ± 7.5 |
| IPSS Change at 60 Months | -8.2 ± 7.3 | -10.0 ± 0.0 |
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.
| score on a scale | Subjects With Baseline IPSS 13-19 | Subjects With Baseline IPSS 20-25 | Subjects With Baseline IPSS 26-35 |
|---|---|---|---|
| IPSS Change at 1 Week | 1.8 ± 4.9 | -2.9 ± 9.1 | -0.1 ± 10.2 |
| IPSS Change at 1 Month | -3.3 ± 7.0 | -5.4 ± 8.7 | -9.0 ± 10.6 |
| IPSS Change at 3 Months | -9.7 ± 5.4 | -13.9 ± 7.1 | -21.4 ± 5.5 |
| IPSS Change at 6 Months | -9.2 ± 5.8 | -14.1 ± 7.7 | -19.7 ± 8.9 |
| IPSS Change at 12 Months | -8.2 ± 5.0 | -14.6 ± 7.6 | -19.2 ± 9.2 |
| IPSS Change at 24 Months | -7.9 ± 5.2 | -12.9 ± 8.9 | -20.6 ± 9.2 |
| IPSS Change at 36 Months | -6.9 ± 5.2 | -9.0 ± 10.9 | -20.7 ± 4.0 |
| IPSS Change at 48 Months | -7.2 ± 5.2 | -9.8 ± 8.3 | -17.7 ± 8.0 |
| IPSS Change at 60 Months | -7.7 ± 4.7 | -3.5 ± 7.8 | -14.5 ± 6.4 |
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.
| score on a scale | Rezum Treatment |
|---|---|
| Pain Score on day of Treatment | 4.0 ± 3.3 |
| Pain Score 1 Day Post-Treatment | 1.9 ± 2.3 |
| Pain Score 1 Week Post-Treatment | 1.9 ± 2.6 |
| Pain Score 1 Month Post-Treatment | 1.2 ± 2.1 |
| Pain Score 3 Months Post-Treatment | 0.5 ± 1.6 |
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.
| score on a scale | Rezum Treatment |
|---|---|
| Change from Baseline in IPSS QoL Score at 1 Week | -0.3 ± 1.4 |
| Change from Baseline in IPSS QoL Score at 1 Month | -1.1 ± 1.8 |
| Change from Baseline in IPSS QoL Score at 3 Months | -2.7 ± 1.6 |
| Change from Baseline in IPSS QoL Score at 6 Months | -2.7 ± 1.7 |
| Change from Baseline in IPSS QoL Score at 12 Months | -2.7 ± 1.5 |
| Change in IPSS QoL Change from Baseline in IPSS QoL Score at 24 Months | -2.6 ± 1.7 |
| Change from Baseline in IPSS QoL Score at 36 Months | -2.4 ± 2.1 |
| Change from Baseline in IPSS QoL Score at 48 Months | -2.5 ± 1.6 |
| Change from Baseline in IPSS QoL Score at 60 Months | -1.6 ± 1.8 |
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.
| score on a scale | Rezum Treatment |
|---|---|
| Change from Baseline in BPHII Score at 1 Month | -1.0 ± 3.7 |
| Change from Baseline in BPHII Score at 3 Months | -4.4 ± 2.9 |
| Change from Baseline in BPHII Score at 6 Months | -4.5 ± 3.1 |
| Change from Baseline in BPHII Score at 12 Months | -4.3 ± 2.8 |
| Change from Baseline in BPHII Score at 24 Months | -4.4 ± 3.2 |
| Change from Baseline in BPHII Score at 36 Months | -3.5 ± 4.0 |
| Change from Baseline in BPHII Score at 48 Months | -4.0 ± 3.5 |
| Change from Baseline in BPHII Score at 60 Months | -2.1 ± 4.2 |
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.
| score on a scale | Rezum Treatment |
|---|---|
| Change from Baseline in EQ-5D-3L Overall Score at 1 Month | -0.0 ± 0.2 |
| Change from Baseline in EQ-5D-3L Overall Score at 3 Month | 0.0 ± 0.2 |
| Change from Baseline in EQ-5D-3L Overall Score at 6 Month | 0.1 ± 0.1 |
| Change from Baseline in EQ-5D-3L Overall Score at 12 Month | 0.0 ± 0.1 |
| Change from Baseline in EQ-5D-3L Overall Score at 24 Month | 0.0 ± 0.1 |
| Change from Baseline in EQ-5D-3L Overall Score at 36 Month | 0.0 ± 0.1 |
| Change from Baseline in EQ-5D-3L Overall Score at 48 Month | -0.0 ± 0.2 |
| Change from Baseline in EQ-5D-3L Overall Score at 60 Month | -0.1 ± 0.1 |
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.
| score on a scale | Rezum Treatment |
|---|---|
| Change from Baseline in EQ-5D-3L VAS Score at 1 Month | 2.8 ± 18.0 |
| Change from Baseline in EQ-5D-3L VAS Score at 3 Month | 8.3 ± 18.3 |
| Change from Baseline in EQ-5D-3L VAS Score at 6 Month | 9.1 ± 14.5 |
| Change from Baseline in EQ-5D-3L VAS Score at 12 Month | 7.4 ± 19.7 |
| Change from Baseline in EQ-5D-3L VAS Score at 24 Month | 5.8 ± 18.3 |
| Change from Baseline in EQ-5D-3L VAS Score at 36 Month | 9.2 ± 20.9 |
| -0.1Change from Baseline in EQ-5D-3L VAS Score at 48 Month | 6.5 ± 17.9 |
| Change from Baseline in EQ-5D-3L VAS Score at 60 Month | -0.1 ± 11.9 |
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.
| Participants | Rezum Treatment |
|---|---|
| Baseline_Anxiety Dimension Score — Level 1 (No Problems) | 32 |
| Baseline_Anxiety Dimension Score — Level 2 (Some Problems) | 16 |
| Baseline_Anxiety Dimension Score — Level 3 (Extreme Problems) | 2 |
| 1 Month_Anxiety Dimension Score — Level 1 (No Problems) | 39 |
| 1 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 8 |
| 1 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 2 |
| 3 Month_Anxiety Dimension Score — Level 1 (No Problems) | 41 |
| 3 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 6 |
| 3 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| 6 Month_Anxiety Dimension Score — Level 1 (No Problems) | 40 |
| 6 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 6 |
| 6 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| 12 Month_Anxiety Dimension Score — Level 1 (No Problems) | 35 |
| 12 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 10 |
| 12 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| 24 Month_Anxiety Dimension Score — Level 1 (No Problems) | 26 |
| 24 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 8 |
| 24 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| 36 Month_Anxiety Dimension Score — Level 1 (No Problems) | 22 |
| 36 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 5 |
| 36 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| 48 Month_Anxiety Dimension Score — Level 1 (No Problems) | 19 |
| 48 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 7 |
| 48 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| 60 Month_Anxiety Dimension Score — Level 1 (No Problems) | 5 |
| 60 Month_Anxiety Dimension Score — Level 2 (Some Problems) | 2 |
| 60 Month_Anxiety Dimension Score — Level 3 (Extreme Problems) | 0 |
| Baseline_Mobility Dimension Score — Level 1 (No Problems) | 43 |
| Baseline_Mobility Dimension Score — Level 2 (Some Problems) | 7 |
| Baseline_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 1 Month_Mobility Dimension Score — Level 1 (No Problems) | 43 |
| 1 Month_Mobility Dimension Score — Level 2 (Some Problems) | 6 |
| 1 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 3 Month_Mobility Dimension Score — Level 1 (No Problems) | 43 |
| 3 Month_Mobility Dimension Score — Level 2 (Some Problems) | 5 |
| 3 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 6 Month_Mobility Dimension Score — Level 1 (No Problems) | 40 |
| 6 Month_Mobility Dimension Score — Level 2 (Some Problems) | 6 |
| 6 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 12 Month_Mobility Dimension Score — Level 1 (No Problems) | 37 |
| 12 Month_Mobility Dimension Score — Level 2 (Some Problems) | 8 |
| 12 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 24 Month_Mobility Dimension Score — Level 1 (No Problems) | 27 |
| 24 Month_Mobility Dimension Score — Level 2 (Some Problems) | 7 |
| 24 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 36 Month_Mobility Dimension Score — Level 1 (No Problems) | 17 |
| 36 Month_Mobility Dimension Score — Level 2 (Some Problems) | 10 |
| 36 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 48 Month_Mobility Dimension Score — Level 1 (No Problems) | 15 |
| 48 Month_Mobility Dimension Score — Level 2 (Some Problems) | 10 |
| 48 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| 60 Month_Mobility Dimension Score — Level 1 (No Problems) | 3 |
| 60 Month_Mobility Dimension Score — Level 2 (Some Problems) | 4 |
| 60 Month_Mobility Dimension Score — Level 3 (Extreme Problems) | 0 |
| Baseline_Pain Dimension Score — Level 1 (No Problems) | 22 |
| Baseline_Pain Dimension Score — Level 2 (Some Problems) | 25 |
| Baseline_Pain Dimension Score — Level 3 (Extreme Problems) | 1 |
| 1 Month_Pain Dimension Score — Level 1 (No Problems) | 24 |
| 1 Month_Pain Dimension Score — Level 2 (Some Problems) | 20 |
| 1 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 2 |
| 3 Month_Pain Dimension Score — Level 1 (No Problems) | 32 |
| 3 Month_Pain Dimension Score — Level 2 (Some Problems) | 15 |
| 3 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 1 |
| 6 Month_Pain Dimension Score — Level 1 (No Problems) | 30 |
| 6 Month_Pain Dimension Score — Level 2 (Some Problems) | 16 |
| 6 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 0 |
| 12 Month_Pain Dimension Score — Level 1 (No Problems) | 28 |
| 12 Month_Pain Dimension Score — Level 2 (Some Problems) | 16 |
| 12 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 0 |
| 24 Month_Pain Dimension Score — Level 1 (No Problems) | 20 |
| 24 Month_Pain Dimension Score — Level 2 (Some Problems) | 12 |
| 24 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 1 |
| 36 Month_Pain Dimension Score — Level 1 (No Problems) | 17 |
| 36 Month_Pain Dimension Score — Level 2 (Some Problems) | 9 |
| 36 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 1 |
| 48 Month_Pain Dimension Score — Level 1 (No Problems) | 12 |
| 48 Month_Pain Dimension Score — Level 2 (Some Problems) | 12 |
| 48 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 2 |
| 60 Month_Pain Dimension Score — Level 1 (No Problems) | 4 |
| 60 Month_Pain Dimension Score — Level 2 (Some Problems) | 2 |
| 60 Month_Pain Dimension Score — Level 3 (Extreme Problems) | 1 |
| Baseline_Self-care Dimension Score — Level 1 (No Problems) | 50 |
| Baseline_Self-care Dimension Score — Level 2 (Some Problems) | 0 |
| Baseline_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 1 Month_Self-care Dimension Score — Level 1 (No Problems) | 48 |
| 1 Month_Self-care Dimension Score — Level 2 (Some Problems) | 0 |
| 1 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 1 |
| 3 Month_Self-care Dimension Score — Level 1 (No Problems) | 47 |
| 3 Month_Self-care Dimension Score — Level 2 (Some Problems) | 1 |
| 3 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 6 Month_Self-care Dimension Score — Level 1 (No Problems) | 46 |
| 6 Month_Self-care Dimension Score — Level 2 (Some Problems) | 0 |
| 6 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 12 Month_Self-care Dimension Score — Level 1 (No Problems) | 45 |
| 12 Month_Self-care Dimension Score — Level 2 (Some Problems) | 0 |
| 12 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 24 Month_Self-care Dimension Score — Level 1 (No Problems) | 33 |
| 24 Month_Self-care Dimension Score — Level 2 (Some Problems) | 1 |
| 24 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 36 Month_Self-care Dimension Score — Level 1 (No Problems) | 26 |
| 36 Month_Self-care Dimension Score — Level 2 (Some Problems) | 1 |
| 36 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 48 Month_Self-care Dimension Score — Level 1 (No Problems) | 24 |
| 48 Month_Self-care Dimension Score — Level 2 (Some Problems) | 1 |
| 48 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| 60 Month_Self-care Dimension Score — Level 1 (No Problems) | 6 |
| 60 Month_Self-care Dimension Score — Level 2 (Some Problems) | 1 |
| 60 Month_Self-care Dimension Score — Level 3 (Extreme Problems) | 0 |
| Baseline_Usual Activity Dimension Score — Level 1 (No Problems) | 47 |
| Baseline_Usual Activity Dimension Score — Level 2 (Some Problems) | 3 |
| Baseline_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
| 1 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 40 |
| 1 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 7 |
| 1 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 2 |
| 3 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 45 |
| 3 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 3 |
| 3 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
| 6 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 46 |
| 6 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 0 |
| 6 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
| 12 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 41 |
| 12 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 4 |
| 12 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
| 24 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 31 |
| 24 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 3 |
| 24 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
| 36 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 25 |
| 36 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 2 |
| 36 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
| 48 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 20 |
| 48 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 4 |
| 48 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 1 |
| 60 Month_Usual Activity Dimension Score — Level 1 (No Problems) | 6 |
| 60 Month_Usual Activity Dimension Score — Level 2 (Some Problems) | 1 |
| 60 Month_Usual Activity Dimension Score — Level 3 (Extreme Problems) | 0 |
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.
| Participants | Rezum Treatment |
|---|---|
| Proportion of subjects satisfied with the procedure at 1 Week — Very Satisfied | 16 |
| Proportion of subjects satisfied with the procedure at 1 Week — Satisfied | 23 |
| Proportion of subjects satisfied with the procedure at 1 Week — Neither Satisfied or Dissatisfied (Neutral) | 6 |
| Proportion of subjects satisfied with the procedure at 1 Week — Dissatisfied | 2 |
| Proportion of subjects satisfied with the procedure at 1 Week — Very Dissatisfied | 1 |
| Proportion of subjects satisfied with the procedure at 1 Month — Very Satisfied | 18 |
| Proportion of subjects satisfied with the procedure at 1 Month — Satisfied | 19 |
| Proportion of subjects satisfied with the procedure at 1 Month — Neither Satisfied or Dissatisfied (Neutral) | 8 |
| Proportion of subjects satisfied with the procedure at 1 Month — Dissatisfied | 2 |
| Proportion of subjects satisfied with the procedure at 1 Month — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 3 Months — Very Satisfied | 21 |
| Proportion of subjects satisfied with the procedure at 3 Months — Satisfied | 22 |
| Proportion of subjects satisfied with the procedure at 3 Months — Neither Satisfied or Dissatisfied (Neutral) | 3 |
| Proportion of subjects satisfied with the procedure at 3 Months — Dissatisfied | 1 |
| Proportion of subjects satisfied with the procedure at 3 Months — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 6 Months — Very Satisfied | 18 |
| Proportion of subjects satisfied with the procedure at 6 Months — Satisfied | 20 |
| Proportion of subjects satisfied with the procedure at 6 Months — Neither Satisfied or Dissatisfied (Neutral) | 7 |
| Proportion of subjects satisfied with the procedure at 6 Months — Dissatisfied | 2 |
| Proportion of subjects satisfied with the procedure at 6 Months — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 12 Months — Very Satisfied | 19 |
| Proportion of subjects satisfied with the procedure at 12 Months — Satisfied | 19 |
| Proportion of subjects satisfied with the procedure at 12 Months — Neither Satisfied or Dissatisfied (Neutral) | 6 |
| Proportion of subjects satisfied with the procedure at 12 Months — Dissatisfied | 1 |
| Proportion of subjects satisfied with the procedure at 12 Months — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 24 Months — Very Satisfied | 12 |
| Proportion of subjects satisfied with the procedure at 24 Months — Satisfied | 12 |
| Proportion of subjects satisfied with the procedure at 24 Months — Neither Satisfied or Dissatisfied (Neutral) | 3 |
| Proportion of subjects satisfied with the procedure at 24 Months — Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 24 Months — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 36 Months — Very Satisfied | 11 |
| Proportion of subjects satisfied with the procedure at 36 Months — Satisfied | 8 |
| Proportion of subjects satisfied with the procedure at 36 Months — Neither Satisfied or Dissatisfied (Neutral) | 4 |
| Proportion of subjects satisfied with the procedure at 36 Months — Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 36 Months — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 48 Months — Very Satisfied | 10 |
| Proportion of subjects satisfied with the procedure at 48 Months — Satisfied | 11 |
| Proportion of subjects satisfied with the procedure at 48 Months — Neither Satisfied or Dissatisfied (Neutral) | 3 |
| Proportion of subjects satisfied with the procedure at 48 Months — Dissatisfied | 2 |
| Proportion of subjects satisfied with the procedure at 48 Months — Very Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 60 Months — Very Satisfied | 1 |
| Proportion of subjects satisfied with the procedure at 60 Months — Satisfied | 4 |
| Proportion of subjects satisfied with the procedure at 60 Months — Neither Satisfied or Dissatisfied (Neutral) | 2 |
| Proportion of subjects satisfied with the procedure at 60 Months — Dissatisfied | 0 |
| Proportion of subjects satisfied with the procedure at 60 Months — Very Dissatisfied | 0 |
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.
| Participants | Rezum Treatment |
|---|---|
| Proportion of subjects who would recommend procedure to friends/family at 1 Week — Definitely Will | 26 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Week — Probably Will | 14 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Week — Not Sure | 7 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Week — Probably Will Not | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Week — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Month — Definitely Will | 24 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Month — Probably Will | 16 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Month — Not Sure | 6 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Month — Probably Will Not | 2 |
| Proportion of subjects who would recommend procedure to friends/family at 1 Month — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 3 Months — Definitely Will | 33 |
| Proportion of subjects who would recommend procedure to friends/family at 3 Months — Probably Will | 10 |
| Proportion of subjects who would recommend procedure to friends/family at 3 Months — Not Sure | 4 |
| Proportion of subjects who would recommend procedure to friends/family at 3 Months — Probably Will Not | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 3 Months — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 6 Months — Definitely Will | 29 |
| Proportion of subjects who would recommend procedure to friends/family at 6 Months — Probably Will | 12 |
| Proportion of subjects who would recommend procedure to friends/family at 6 Months — Not Sure | 5 |
| Proportion of subjects who would recommend procedure to friends/family at 6 Months — Probably Will Not | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 6 Months — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 12 Months — Definitely Will | 30 |
| Proportion of subjects who would recommend procedure to friends/family at 12 Months — Probably Will | 12 |
| Proportion of subjects who would recommend procedure to friends/family at 12 Months — Not Sure | 3 |
| Proportion of subjects who would recommend procedure to friends/family at 12 Months — Probably Will Not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 12 Months — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 24 Months — Definitely Will | 18 |
| Proportion of subjects who would recommend procedure to friends/family at 24 Months — Probably Will | 8 |
| Proportion of subjects who would recommend procedure to friends/family at 24 Months — Not Sure | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 24 Months — Probably Will Not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 24 Months — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 36 Months — Definitely Will | 17 |
| Proportion of subjects who would recommend procedure to friends/family at 36 Months — Probably Will | 5 |
| Proportion of subjects who would recommend procedure to friends/family at 36 Months — Not Sure | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 36 Months — Probably Will Not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 36 Months — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 48 Months — Definitely Will | 17 |
| Proportion of subjects who would recommend procedure to friends/family at 48 Months — Probably Will | 8 |
| Proportion of subjects who would recommend procedure to friends/family at 48 Months — Not Sure | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 48 Months — Probably Will Not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 48 Months — Definitely Will not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 60 Months — Definitely Will | 4 |
| Proportion of subjects who would recommend procedure to friends/family at 60 Months — Probably Will | 1 |
| Proportion of subjects who would recommend procedure to friends/family at 60 Months — Not Sure | 2 |
| Proportion of subjects who would recommend procedure to friends/family at 60 Months — Probably Will Not | 0 |
| Proportion of subjects who would recommend procedure to friends/family at 60 Months — Definitely Will not | 0 |
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.
| Participants | Rezum Treatment |
|---|---|
| Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 23 |
| Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 17 |
| Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 6 |
| Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 1 |
| Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
| Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 17 |
| Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 21 |
| Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 8 |
| Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 2 |
| Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
| Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 27 |
| Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 15 |
| Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 5 |
| Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 0 |
| Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
| Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 25 |
| Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 13 |
| Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 8 |
| Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 1 |
| Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
| Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 29 |
| Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 10 |
| Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 5 |
| Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 0 |
| Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 1 |
| Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 12 |
| Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 12 |
| Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 2 |
| Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 0 |
| Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 1 |
| Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 10 |
| Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 8 |
| Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 2 |
| Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 3 |
| Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
| Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 12 |
| Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 8 |
| Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 5 |
| Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 1 |
| Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
| Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Likely | 1 |
| Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Likely | 3 |
| Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Not Sure | 3 |
| Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Unlikely | 0 |
| Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur — Very Unlikely | 0 |
Procedure time: Time from delivery device insertion to final delivery device withdrawal
| minutes | Rezum Treatment |
|---|---|
| Procedural Parameters - Procedure Time | 6.7 ± 5.8 |
Treatment time: time from first vapor delivery to last vapor delivery
| minutes | Rezum Treatment |
|---|---|
| Procedural Parameters - Treatment Time | 4.5 ± 4.9 |
Collected over Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rezum Treatment | 2/50 (4%) | 8/50 (16%) | 38/50 (76%) |
| Event | Rezum Treatment |
|---|---|
| Urinary RetentionRenal and urinary disorders | 3/50 |
| OtherGeneral disorders | 2/50 |
| Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 1/50 |
| Cardiac EventCardiac disorders | 1/50 |
| Pain/Discomfort - PelvicMusculoskeletal and connective tissue disorders | 1/50 |
| Urinary FrequencyRenal and urinary disorders | 1/50 |
| Weakness or FatigueGastrointestinal disorders | 1/50 |
| DiarrheaGastrointestinal disorders | 1/50 |
| Cancer -OtherRenal and urinary disorders | 1/50 |
| Urinary Tract Infection-ProvenRenal and urinary disorders | 1/50 |
| Event | Rezum Treatment |
|---|---|
| Urinary RetentionRenal and urinary disorders | 15/50 |
| Urinary UrgencyRenal and urinary disorders | 15/50 |
| DysuriaRenal and urinary disorders | 10/50 |
| UTI - SuspectedRenal and urinary disorders | 9/50 |
| Poor StreamRenal and urinary disorders | 8/50 |
| Pain/DiscomfortGeneral disorders | 7/50 |
| NocturiaRenal and urinary disorders | 6/50 |
| OtherGeneral disorders | 4/50 |
| Hematuria - GrossRenal and urinary disorders | 4/50 |
| Urinary Incontinence - UrgeRenal and urinary disorders | 3/50 |
Consecutive subjects who met inclusion/exclusion criteria and consented to participate were enrolled and treated with the NxThera Rezūm System.
| Age, Continuous(years) | Rezum Treatment |
|---|---|
| Mean | 65.5 ± 7.1 |
| Sex: Female, Male(Participants) | Rezum Treatment |
|---|---|
| Female | 0 |
| Male | 50 |
| Race/Ethnicity, Customized(Participants) | Rezum Treatment |
|---|---|
| Ethnicity — Black or African Origin | 2 |
| Ethnicity — Caucasian | 45 |
| Ethnicity — Hispanic or Latino | 3 |
| Region of Enrollment(participants) | Rezum Treatment |
|---|---|
| Sweden | 27 |
| Czechia | 18 |
| Dominican Republic | 5 |
Plan to share: No
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