Prostatic HyperplasiaRezum PilotNCT02943070
Rezum I Pilot Study for Benign Prostatic Hyperplasia
A study testing Rezum System in people with Prostatic Hyperplasia and Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 3 sites in 3 countries.
Trial summary
Evaluate the safety and efficacy of the Rezum System for the treatment of BPH Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign Prostatic Hyperplasia, Adenoma, Prostatic
- What is being tested?
- Rezum System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
- IPSS score of ≥ 15.
- Qmax: Peak flow rate ≤ 15 ml/sec.
- Post-void residual (PVR) < 300 ml.
- Prostate transverse diameter > 30 mm.
- Prostate volume between 20 to 120 gm.
Show all 9Show fewer
- Voided volume ≥ 125 mL
- Subject able to complete the study protocol in the opinion of the investigator.
- Life expectancy of at least one year.
Who cannot join
- 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.
Show all 32Show fewer
- 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:
- Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
- Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
- Use of 5-alpha reductase inhibitor within the last 6 months
- Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
Evaluate the safety and efficacy of the Rezum System for the treatment of BPH
Read the detailed description
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.
- Conditions
- Prostatic Hyperplasia, Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy
- Being tested
- Rezum System
- Keywords
- Rezum, Water Vapor Ablation
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezum SystemDevice
Also called Rezum Procedure, Rezum, Water Vapor Ablation, Rezum Delivery 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.
| Study group | Role | What they receive |
|---|---|---|
| Rezum Treatment | Experimental | Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Receives: Device: Rezum System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Severe Urinary Retention (Retention ≥ 24 hours)
- Fistula between rectum and urethra
- Perforation of the rectum or GI tract
- New incidences of retrograde ejaculation
Measured: 3 months
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day of Procedure
Procedural Parameters - Treatment Time
Treatment time: time from first vapor delivery to last vapor delivery
Measured: Day of Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin M Hagelin, Study director, Program Manager, Clinical Affairs, Boston Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943070
- Sponsor's protocol ID
- 1189-001
- Acronym
- Rezum Pilot
- Status last verified
- Feb 2021
- First submitted
- 16 Oct 2012
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
- ClinicalTrials.gov ID
- NCT02943070
- Acronym / sponsor ID
- Rezum Pilot / 1189-001
- Conditions
- Prostatic Hyperplasia, Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy
- Keywords
- Rezum, Water Vapor Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and efficacy of the Rezum System for the treatment of BPH
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rezum Treatment | Experimental | Device: Rezum SystemPatients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
- IPSS score of ≥ 15.
- Qmax: Peak flow rate ≤ 15 ml/sec.
- Post-void residual (PVR) < 300 ml.
- Prostate transverse diameter > 30 mm.
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rezum SystemAlso: Rezum Procedure, Rezum, Water Vapor Ablation, Rezum Delivery DeviceThe 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. | Device | Rezum Treatment |
Primary outcome
International Prostate Symptom Score (IPSS) Change From Baseline
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
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.
Major Complications
Time frame: 3 months
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
23 secondary outcomes
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement
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
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
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)
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
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
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
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Change in Sexual Function - Erectile Function
Time frame: 1 month, 3 months, 6 months, 1 year, annually to 5 years
Change in Sexual Function - Retrograde Ejaculation
Time frame: 1 Week post procedure, 1 Month post procedure, 3 Months post procedure
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume
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
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
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Procedural Pain Score
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)
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)
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
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)
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
Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years
Subject Satisfaction - Satisfied With Overall Procedure
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
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
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years
Procedural Parameters - Procedure Time
Time frame: Day of Procedure
Procedural Parameters - Treatment Time
Time frame: Day of Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin M Hagelin study director
Program Manager, Clinical Affairs, Boston Scientific
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezum System in people with Prostatic Hyperplasia and Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Dominican Republic, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) Change From Baseline (time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.