Rezum I Pilot Study for Benign Prostatic Hyperplasia

Boston Scientific Corporation50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Hyperplasia Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum

Interventions

Rezum SystemDEVICE

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.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male subjects \> 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention. 2. IPSS score of ≥ 15. 3. Qmax: Peak flow rate ≤ 15 ml/sec. 4. Post-void residual (PVR) \< 300 ml. 5. Prostate transverse diameter \> 30 mm. 6. Prostate volume between 20 to 120 gm. 7. Voided volume ≥ 125 mL 8. Subject able to complete the study protocol in the opinion of the investigator. 9. Life expectancy of at least one year. Exclusion Criteria: 1. History of any illness or surgery that may confound the results of the study or have risk to subject. 2. Presence of a penile implant. 3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH. 4. Currently enrolled or has been enrolled in another trial in the past 30 days. 5. Confirmed or suspected malignancy of prostate or bladder 6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease. 7. Previous pelvic irradiation or radical pelvic surgery. 8. 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) 9. Neurogenic bladder or sphincter abnormalities. 10. Urethral strictures, bladder neck contracture or muscle spasms. 11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.) 12. Subjects interested in maintaining fertility. 13. Use of concomitant medications to include the following: 1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes). 2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment. 3. Use of 5-alpha reductase inhibitor within the last 6 months 4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing 14. Subject is unable or unwilling to go through the "washout" period prior to treatment. 15. Subject has chronic urinary retention. 16. Post-void residual volume \> 300 ml. 17. Significant urge incontinence. 18. Poor detrusor muscle function. 19. Neurological disorders which might affect bladder or sphincter function. 20. Urinary sphincter abnormalities. 21. Bladder stones. 22. Evidence of bacterial prostatitis or symptoms of epididymitis 23. Renal impairment or serum creatinine \> 2.0 mg/dl 24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well. 25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements. 26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study. 27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum). 28. Biopsy of prostate within 30 days of procedure.

Locations (3)

University Hospital

Brno, Czechia

Clinica Canela

La Romana, Dominican Republic

Urologcentrum

Stockholm, Sweden

Outcomes

Primary Outcomes

International Prostate Symptom Score (IPSS) Change From Baseline

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Major Complications

Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: 1. Severe Urinary Retention (Retention ≥ 24 hours) 2. Fistula between rectum and urethra 3. Perforation of the rectum or GI tract 4. New incidences of retrograde ejaculation

Time frame: 3 months

Secondary Outcomes

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Data from ClinicalTrials.gov

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Change in Sexual Function - Erectile Function

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

Time frame: 1 month, 3 months, 6 months, 1 year, annually to 5 years

Change in Sexual Function - Retrograde Ejaculation

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

Time frame: 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

International Prostate Symptom Score (IPSS) Assessment by Prostate Volume

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

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

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

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Procedural Pain Score

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

Time frame: Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)

Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit. One question in the IPSS asked subjects to rate their "quality of life due to urinary symptoms" on a scale of 0 = Delighted to 6 = Terrible. A reduction in score from baseline equates to improved outcome.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)

Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits. BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.

Time frame: Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L

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

Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)

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

Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L

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

Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Subject Satisfaction - Satisfied With Overall Procedure

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. These will be measured as: • Proportion of subjects that are satisfied with the procedure overall Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects that would recommend this treatment to friends and families Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Procedural Parameters - Procedure Time

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

Time frame: Day of Procedure

Procedural Parameters - Treatment Time

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

Time frame: Day of Procedure