BPH, BPH With Urinary Obstruction, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Conditions
Keywords
BPH, Minimally Invasive, Water Vapor Therapy, Rezum
Brief summary
Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.
Detailed description
A prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.
Interventions
DEVICEProstatic Vapor Ablation
Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male subjects ≥ 50 years of age who have symptomatic BPH. 2. International Prostate Symptom Score (IPSS) score ≥ 13. 3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml. 4. Post-void residual (PVR) ≤300 ml. 5. Prostate volume \>80 cm3 to ≤150 cm3
Exclusion criteria
Urology: 1. Any prior invasive prostate intervention (e.g., Radiofrequency thermotherapy, balloon, microwave thermotherapy, Prostatic Urethral Lift, Transurethral Resection, or laser) or other surgical interventions of the prostate. 2. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery. 3. Verified acute bacterial prostatitis within last 12 months documented by culture. 4. Active or history of epididymitis within the past 3 months. 5. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device. 6. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible. 7. Subject interested in maintaining fertility. 8. Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months): 1. Beta-blockers; 2. Anticonvulsants; 3. Antispasmodics; 4. Antihistamines; 5. Alpha blockers for BPH and anticholinergics or cholinergics; 6. Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia)); 7. Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)); 8. Estrogen, drug-producing androgen suppression, or anabolic steroids; 9. PD5 Inhibitors (e.g., Viagra, Levitra or Cialis) 9. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible 10. Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment. 11. Visible hematuria with subject urine sample without a known contributing factor. 12. Presence of a penile implant or stent(s) in the urethra or prostate 13. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months. Gastroenterology: 14. Previous pelvic irradiation or radical pelvic surgery. 15. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease. Nephrology: 16. Compromised renal function defined as serum creatinine \> 2.0 mg/dl. 17. Hydronephrosis (Grade 2 or higher). Oncology: 18. Prostate cancer testing: If PSA is \> 2.5 ng/ml and ≤ 10 ng/ml with free PSA \<25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment * Males 50-59 years - PSA is \>2.5 ng/ml and ≤10 ng/ml with free PSA \<25%, * Males 60+ years - PSA is \>4 ng/ml and ≤10 ng/ml, with free PSA \<25% 19. History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial PIN is acceptable. 20. History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of enrollment. Cardiology: 21. History of clinically significant congestive heart failure (i.e., NYHA Class III and IV). 22. Cardiac arrhythmias that are not controlled by medication and/or medical device. 23. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months. Pulmonology: 24. History of significant respiratory disease where hospitalization for the disease is required. Hematology: 25. Diagnosed or suspected bleeding disorder, or coagulopathies. 26. Use of antiplatelet or anticoagulant medication except low dose aspirin (\<100mg/day) within 10 days prior to treatment. Endocrinology: 27. History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c \<8.0% are allowed. Immunology: 28. History of immunosuppressive conditions (e.g., AIDS, post-transplant). Neurology: 29. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires. 30. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function (\< 25% of accepted and established nomograms). General: 31. Currently enrolled in any other pre-approval investigational study in the US (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.). 32. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study. 33. Inability to provide a legally effective Informed Consent Form and/or comply with all the required follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS) | 6 Months | The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) \> 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score. |
| Number of Participants With Post Procedure Device Related Serious Complications | 6 Months | Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Device-related Retention Catheterizations | 6 Month | This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months. |
| Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up | Baseline, 6 weeks, 3 months, 6 months, 1 year | The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score. |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Prostatic Vapor Ablation with Rezum
Prostatic Vapor Ablation: Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was terminated for business reasons | 47 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 40 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 41 / 47 |
| serious Total, serious adverse events | 4 / 47 |
Outcome results
Primary
Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) \> 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time frame: 6 Months
Population: All subjects enrolled were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS) | 39 Participants |
Primary
Number of Participants With Post Procedure Device Related Serious Complications
Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Time frame: 6 Months
Population: All subjects enrolled were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Post Procedure Device Related Serious Complications | 0 Participants |
Secondary
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Population: All subjects with data at both baseline and the follow-up visit were included in the analysis (N=47 at 6 weeks, 3 months, 6 months; N=42 at 12 months).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment | Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up | Change from baseline to 6 weeks post-therapy | -8.47 score on a scale |
| Treatment | Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up | Change from baseline to 3 months post-therapy | -10.97 score on a scale |
| Treatment | Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up | Change from baseline to 6 months post-therapy | -11.62 score on a scale |
| Treatment | Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up | Change from baseline to 12 months post-therapy | -11.80 score on a scale |
Secondary
Number of Subjects With Device-related Retention Catheterizations
This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Time frame: 6 Month
Population: All subjects enrolled were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Subjects With Device-related Retention Catheterizations | 0 Participants |