Rezum I Pilot Study for Benign Prostatic Hyperplasia

Not Applicable

Completed

Conditions: Prostatic Adenoma
Prostatic Hyperplasia
Prostatic Hypertrophy
Rezum
Benign Prostatic Hyperplasia
Adenoma, Prostatic
Prostatic Hyperplasia, Benign
Prostatic Hypertrophy, Benign

Interventions: Device: Rezum System

Registration Number: NCT02943070

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 50

Inclusion Criteria

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.
Voided volume ≥ 125 mL
Subject able to complete the study protocol in the opinion of the investigator.
Life expectancy of at least one year.

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:
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
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rezum Treatment	Rezum System	Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) Change From Baseline	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	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

Secondary Outcome Measures

Name	Time	Method
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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.
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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.
Change in Sexual Function - Erectile Function	1 month, 3 months, 6 months, 1 year, annually to 5 years	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)
Procedural Pain Score	Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure	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.
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	1 month, 3 months, 6 months, 1 year, then annually to 5 years	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.
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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.
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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.
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years	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.
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years	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.
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 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 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.
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 month, 3 months, 6 months, 1 year, then annually to 5 years	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.
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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.
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	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.
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	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 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.
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	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 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.
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	1 month, 3 months, 6 months, 1 year, then annually to 5 years	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.
Subject Satisfaction - Satisfied With Overall Procedure	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 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. 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.
Procedural Parameters - Treatment Time	Day of Procedure	Treatment time: time from first vapor delivery to last vapor delivery
Change in Sexual Function - Retrograde Ejaculation	1 Week post procedure, 1 Month post procedure, 3 Months post procedure	Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	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 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.
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 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.
Procedural Parameters - Procedure Time	Day of Procedure	Procedure time: Time from delivery device insertion to final delivery device withdrawal