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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezum Treatment | Experimental | Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezum System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
History of any illness or surgery that may confound the results of the study or have risk to subject.
Presence of a penile implant.
Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
Currently enrolled or has been enrolled in another trial in the past 30 days.
Confirmed or suspected malignancy of prostate or bladder
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Previous pelvic irradiation or radical pelvic surgery.
Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catherization specimen)
Neurogenic bladder or sphincter abnormalities.
Urethral strictures, bladder neck contracture or muscle spasms.
Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.)
Subjects interested in maintaining fertility.
Use of concomitant medications to include the following:
Subject is unable or unwilling to go through the "washout" period prior to treatment.
Subject has chronic urinary retention.
Post-void residual volume > 300 ml.
Significant urge incontinence.
Poor detrusor muscle function.
Neurological disorders which might affect bladder or sphincter function.
Urinary sphincter abnormalities.
Bladder stones.
Evidence of bacterial prostatitis or symptoms of epididymitis
Renal impairment or serum creatinine > 2.0 mg/dl
In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.
Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study.
Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
Biopsy of prostate within 30 days of procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin M Hagelin | Program Manager, Clinical Affairs, Boston Scientific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Brno | Czechia | ||||
| Clinica Canela |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rezum Treatment | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Consecutive subjects who met inclusion/exclusion criteria and consented to participate were enrolled and treated with the NxThera Rezūm System.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rezum Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Mean change (improvement) in score was calculated for the number of subjects providing data at each follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
|
Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rezum Treatment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Subject had preexisting Congestive Heart Failure which deteriorated into symptomatic pulmonary edema, subject was hospitalized and treated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
This was a pilot study conducted on a new therapy at a limited number of sites (3 total).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Boston Scientific Corporation | 952-930-6000 | teresa.takle-flach@bsci.com |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
|
| 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. | 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 | 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. | 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. | 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. | 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. | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | Day of Procedure |
| Procedural Parameters - Treatment Time | Treatment time: time from first vapor delivery to last vapor delivery | Day of Procedure |
| La Romana |
| Dominican Republic |
| Urologcentrum | Stockholm | Sweden |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Retreatment or TURP |
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| Subjects exited after their 48 month visit per the Sponsor's decision to close the study. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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:
| Incidence of device-related complications pre-specified under this safety endpoint assessed through 3 months post-implant. | Posted | Number | clinically relevant complications | 3 months |
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| Secondary | 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. | Subjects with data at baseline and at the follow-up visit are included in the data summarization. | Posted | Count of Participants | Participants | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visits are included in the data summarization. | Posted | Count of Participants | Participants | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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 | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Count of Participants | Participants | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Mean change in urinary flow rate was calculated for subjects with data at baseline and follow-up visit. | Posted | Mean | Standard Deviation | mL/sec | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Measure calculated for subjects with data at baseline and follow-up visit. | Posted | Count of Participants | Participants | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Measure calculated for subjects with data at baseline and follow-up visit. | Posted | Count of Participants | Participants | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Measure calculated for subjects with data at baseline and follow-up visit. | Posted | Mean | Standard Deviation | ml | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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) | Mean change in total score was calculated for subjects providing data at each follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | Change in Sexual Function - Retrograde Ejaculation | Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm) | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Count of Participants | Participants | 1 Week post procedure, 1 Month post procedure, 3 Months post procedure |
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| Secondary | 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. | Measure calculated for subjects providing data at each follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Secondary | 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. | Subjects with data at the scheduled visits are included in the data summarization. | Posted | Mean | Standard Deviation | score on a scale | Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 3 months, 6 months, 1 year, then annually to 5 years |
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|
| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 3 months, 6 months, 1 year, then annually to 5 years |
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|
| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Count of Participants | Participants | 1 month, 3 months, 6 months, 1 year, then annually to 5 years |
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|
| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Count of Participants | Participants | 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Count of Participants | Participants | 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years |
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| Secondary | 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. | Subjects with data at baseline and follow-up visit are included in the summarization. | Posted | Count of Participants | Participants | 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years |
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| Secondary | Procedural Parameters - Procedure Time | Procedure time: Time from delivery device insertion to final delivery device withdrawal | Subjects with procedure data are included in the summarization. | Posted | Mean | Standard Deviation | minutes | Day of Procedure |
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|
| Secondary | Procedural Parameters - Treatment Time | Treatment time: time from first vapor delivery to last vapor delivery | Subjects with procedure data are included in the summarization. | Posted | Mean | Standard Deviation | minutes | Day of Procedure |
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|
| 2 |
| 50 |
| 8 |
| 50 |
| 38 |
| 50 |
|
| Cardiac Event | Cardiac disorders | Systematic Assessment | Subject with medical history of Hypertension, arrhythmia and diabetes, experienced a myocardial infarction and was hospitalized. A percutaneous transluminal coronary angiogram was done and subject was discharged home. |
|
| Pain/Discomfort - Pelvic | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject reported pain and discomfort in his right hip, and was hospitalized for a surgical revision of right hip endoprothesis coxae due to pain, and restricted, limited motion. The event was resolved after the revision procedure. |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment | Due to worsening urinary retention subject underwent TURP. |
|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment | At one month follow up catheter was removed and subject voided, but later that day had a re-catheterization due to to urinary retention. Subject underwent cystoscopy and a prostatic median lobe was identified. Subject then had a TURP procedure. |
|
| Weakness or Fatigue | Gastrointestinal disorders | Systematic Assessment | The subject reported having fatigue, weakness and diarrhea, and was hospitalized. The subject was diagnosed with Salmonella enteritis and treated with antibiotics. |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | The subject reported having fatigue, weakness and diarrhea, and was hospitalized. The subject was diagnosed with Salmonella enteritis and treated with antibiotics. |
|
| Cancer -Other | Renal and urinary disorders | Systematic Assessment | The subject reported undergoing a routine preventive colonoscopy and a tumor of the hepatic flexure in the colon was detected. Subject had a right hemi colectomy performed. |
|
| Urinary Tract Infection-Proven | Renal and urinary disorders | Systematic Assessment | Subject reported sudden onset of fever (40C) and voided grayish appearing material. Subject hospitalized and was diagnosed with urosepsis. Subject was treated with Ciprofloxacin and event resolved. |
|
| Poor Stream | Renal and urinary disorders | Systematic Assessment | At one month follow up catheter was removed and subject voided, but later that day had a re-catheterization due to to urinary retention. Subject underwent cystoscopy and a prostatic median lobe was identified. Subject then had a TURP procedure. |
|
| Other | General disorders | Systematic Assessment | 002-005: Pain/Discomfort-Pelvic; R hip prosthesis revision; Gonarthrosis-subject underwent planned implantation of left knee endoptrothesis. 002-008: L arm pain (surgical repair of joint); Death due to previously unreported metastatic cancer |
|
| Infection Other than UTI | Infections and infestations | Systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Poor Stream | Renal and urinary disorders | Systematic Assessment |
|
| UTI - Suspected | Renal and urinary disorders | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | Systematic Assessment |
|
| Pain/Discomfort | General disorders | Systematic Assessment |
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| Hematuria - Gross | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Incontinence - Urge | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
|
| Hesitancy | Renal and urinary disorders | Systematic Assessment |
|
| Pain/Discomfort - Pelvic | General disorders | Systematic Assessment |
|
| Urethral Secretion w/o Hematuria or Stones | Renal and urinary disorders | Systematic Assessment |
|
| Pain/Discomfort with Scrotum | Renal and urinary disorders | Systematic Assessment |
|
| Abdominal Bloating with Gas | Gastrointestinal disorders | Systematic Assessment |
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| Bladder Spasms | Renal and urinary disorders | Systematic Assessment |
|
| Cancer - Prostate | Renal and urinary disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Epididymitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Injury - Other | General disorders | Systematic Assessment |
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| Pain/Discomfort - Back | General disorders | Systematic Assessment |
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| Pain/Discomfort - Perineum | General disorders | Systematic Assessment |
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| Prostatic Cyst De Novo | Renal and urinary disorders | Systematic Assessment |
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| Spinal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Terminal Dribbling | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Incontinence - Not Specified | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D052801 |
| Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| New incidences of retrograde ejaculation |
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|
| Proportion of Responders with>=30% Improvement at 3 Months |
|
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| Proportion of Responders with>=30% Improvement at 6 Months |
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| Proportion of Responders with>=30% Improvement at 12 Months |
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| Proportion of Responders with>=30% Improvement at 24 Months |
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|
| Proportion of Responders with>=30% Improvement at 36 Months |
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|
| Proportion of Responders with>=30% Improvement at 48 Months |
|
|
| Proportion of Responders with>=30% Improvement at 60 Months |
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|
| 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 |
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|
| Proportion of Responders with a ≥ 50% IPSS Improvement at 60 Months |
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|
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 3 Months |
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|
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 6 Months |
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|
| 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 |
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|
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 48 Months |
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|
| Proportion of Responders With Improvement ≥ 8 Points in IPSS at 60 Months |
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|
|
| Change from baseline in peak urinary flow rate (Qmax) at 3 Months |
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|
| 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 |
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|
| Qmax improvement of 30% or more over baseline at 3 Months |
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|
| Qmax improvement of 30% or more over baseline at 6 Months |
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|
| Qmax improvement of 30% or more over baseline at 12 Months |
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|
| Qmax improvement of 30% or more over baseline at 24 Months |
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|
| Qmax improvement of 30% or more over baseline at 36 Months |
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| Qmax improvement of 30% or more over baseline at 48 months |
|
|
| Qmax improvement of 30% or more over baseline at 60 Months |
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| Subjects with Qmax Improvement of ≥ 3 ml/sec at 3 Months |
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|
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 6 Months |
|
|
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 12 Months |
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| Subjects with Qmax Improvement of ≥ 3 ml/sec at 24 Months |
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|
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 36 Months |
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|
| Subjects with Qmax Improvement of ≥ 3 ml/sec at 48 months |
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| Subjects with Qmax Improvement of ≥ 3 ml/sec at 60 Months |
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|
| Change from baseline in PVR at 3 Months |
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| Change from baseline in PVR at 6 Months |
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| Change from baseline in PVR at 12 Months |
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| Change from baseline in PVR at 24 Months |
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|
| Change from baseline in PVR at 36 Months |
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| Change from baseline in PVR at 48 months |
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|
| Change from baseline in PVR at 60 Months |
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|
| IEFF change from baseline at 6 Months |
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|
| IEFF change from baseline at 12 Months |
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| IEFF change from baseline at 24 Months |
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| IEFF change from baseline at 36 Months |
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| IEFF change from baseline at 48 Months |
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| IEFF change from baseline at 60 Months |
|
|
| Title | Measurements |
|---|---|
|
| IPSS Change at 1 Month |
|
|
| IPSS Change at 3 Months |
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| IPSS Change at 6 Months |
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| IPSS Change at 12 Months |
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| IPSS Change at 24 Months |
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| IPSS Change at 36 Months |
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|
| IPSS Change at 48 Months |
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|
| IPSS Change at 60 Months |
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|
| IPSS Change at 1 Month |
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|
| IPSS Change at 3 Months |
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|
| IPSS Change at 6 Months |
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|
| IPSS Change at 12 Months |
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|
| IPSS Change at 24 Months |
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|
| IPSS Change at 36 Months |
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|
| IPSS Change at 48 Months |
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|
| IPSS Change at 60 Months |
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|
| IPSS Change at 1 Month |
|
|
| IPSS Change at 3 Months |
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|
| IPSS Change at 6 Months |
|
|
| IPSS Change at 12 Months |
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|
| IPSS Change at 24 Months |
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|
| IPSS Change at 36 Months |
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|
| IPSS Change at 48 Months |
|
|
| IPSS Change at 60 Months |
|
|
|
| Pain Score 1 Week Post-Treatment |
|
|
| Pain Score 1 Month Post-Treatment |
|
|
| Pain Score 3 Months Post-Treatment |
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|
|
| Change from Baseline in IPSS QoL Score at 3 Months |
|
|
| Change from Baseline in IPSS QoL Score at 6 Months |
|
|
| Change from Baseline in IPSS QoL Score at 12 Months |
|
|
| Change in IPSS QoL Change from Baseline in IPSS QoL Score at 24 Months |
|
|
| Change from Baseline in IPSS QoL Score at 36 Months |
|
|
| Change from Baseline in IPSS QoL Score at 48 Months |
|
|
| Change from Baseline in IPSS QoL Score at 60 Months |
|
|
|
| Change from Baseline in BPHII Score at 6 Months |
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| Change from Baseline in BPHII Score at 12 Months |
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|
| Change from Baseline in BPHII Score at 24 Months |
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|
| Change from Baseline in BPHII Score at 36 Months |
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|
| Change from Baseline in BPHII Score at 48 Months |
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|
| Change from Baseline in BPHII Score at 60 Months |
|
|
|
| Change from Baseline in EQ-5D-3L Overall Score at 6 Month |
|
|
| Change from Baseline in EQ-5D-3L Overall Score at 12 Month |
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|
| Change from Baseline in EQ-5D-3L Overall Score at 24 Month |
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|
| Change from Baseline in EQ-5D-3L Overall Score at 36 Month |
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|
| Change from Baseline in EQ-5D-3L Overall Score at 48 Month |
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|
| Change from Baseline in EQ-5D-3L Overall Score at 60 Month |
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|
|
| Change from Baseline in EQ-5D-3L VAS Score at 6 Month |
|
|
| Change from Baseline in EQ-5D-3L VAS Score at 12 Month |
|
|
| Change from Baseline in EQ-5D-3L VAS Score at 24 Month |
|
|
| Change from Baseline in EQ-5D-3L VAS Score at 36 Month |
|
|
| -0.1Change from Baseline in EQ-5D-3L VAS Score at 48 Month |
|
|
| Change from Baseline in EQ-5D-3L VAS Score at 60 Month |
|
|
| Level 3 (Extreme Problems) |
|
| 1 Month_Anxiety Dimension Score |
|
|
| 3 Month_Anxiety Dimension Score |
|
|
| 6 Month_Anxiety Dimension Score |
|
|
| 12 Month_Anxiety Dimension Score |
|
|
| 24 Month_Anxiety Dimension Score |
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|
| 36 Month_Anxiety Dimension Score |
|
|
| 48 Month_Anxiety Dimension Score |
|
|
| 60 Month_Anxiety Dimension Score |
|
|
| Baseline_Mobility Dimension Score |
|
|
| 1 Month_Mobility Dimension Score |
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|
| 3 Month_Mobility Dimension Score |
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|
| 6 Month_Mobility Dimension Score |
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|
| 12 Month_Mobility Dimension Score |
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|
| 24 Month_Mobility Dimension Score |
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|
| 36 Month_Mobility Dimension Score |
|
|
| 48 Month_Mobility Dimension Score |
|
|
| 60 Month_Mobility Dimension Score |
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|
| Baseline_Pain Dimension Score |
|
|
| 1 Month_Pain Dimension Score |
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|
| 3 Month_Pain Dimension Score |
|
|
| 6 Month_Pain Dimension Score |
|
|
| 12 Month_Pain Dimension Score |
|
|
| 24 Month_Pain Dimension Score |
|
|
| 36 Month_Pain Dimension Score |
|
|
| 48 Month_Pain Dimension Score |
|
|
| 60 Month_Pain Dimension Score |
|
|
| Baseline_Self-care Dimension Score |
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|
| 1 Month_Self-care Dimension Score |
|
|
| 3 Month_Self-care Dimension Score |
|
|
| 6 Month_Self-care Dimension Score |
|
|
| 12 Month_Self-care Dimension Score |
|
|
| 24 Month_Self-care Dimension Score |
|
|
| 36 Month_Self-care Dimension Score |
|
|
| 48 Month_Self-care Dimension Score |
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|
| 60 Month_Self-care Dimension Score |
|
|
| Baseline_Usual Activity Dimension Score |
|
|
| 1 Month_Usual Activity Dimension Score |
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|
| 3 Month_Usual Activity Dimension Score |
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|
| 6 Month_Usual Activity Dimension Score |
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|
| 12 Month_Usual Activity Dimension Score |
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|
| 24 Month_Usual Activity Dimension Score |
|
|
| 36 Month_Usual Activity Dimension Score |
|
|
| 48 Month_Usual Activity Dimension Score |
|
|
| 60 Month_Usual Activity Dimension Score |
|
|
| Neither Satisfied or Dissatisfied (Neutral) |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Proportion of subjects satisfied with the procedure at 1 Month |
|
|
| Proportion of subjects satisfied with the procedure at 3 Months |
|
|
| Proportion of subjects satisfied with the procedure at 6 Months |
|
|
| Proportion of subjects satisfied with the procedure at 12 Months |
|
|
| Proportion of subjects satisfied with the procedure at 24 Months |
|
|
| Proportion of subjects satisfied with the procedure at 36 Months |
|
|
| Proportion of subjects satisfied with the procedure at 48 Months |
|
|
| Proportion of subjects satisfied with the procedure at 60 Months |
|
|
| Not Sure |
|
| Probably Will Not |
|
| Definitely Will not |
|
| Proportion of subjects who would recommend procedure to friends/family at 1 Month |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 3 Months |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 6 Months |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 12 Months |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 24 Months |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 36 Months |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 48 Months |
|
|
| Proportion of subjects who would recommend procedure to friends/family at 60 Months |
|
|
| Not Sure |
|
| Unlikely |
|
| Very Unlikely |
|
| Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|
| Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur |
|
|