Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A), eDFU
, MB, R
ez
ū
m, en, 50849555-0
1A
Black (K) ∆E ≤5.0
Graph 1. Mean IPSS Over Time.
*Changes relative to baseline are significant, p < 0.001.
Graph 2. Mean Qmax Over Time.
*Changes relative to baseline are significant, p < 0.001.
Graph 3. Mean QoL Over Time.
*Changes relative to baseline are significant, p < 0.001.
REPORTED ADVERSE EVENTS
A summary of the adverse events reported and adjudicated in the Rez
ū
m™ II Pivotal study at
treatment out through report date of February 9, 2019 is presented in the table below. After
unblinding at 3 months, the primary study endpoint, control subjects who elected to proceed
were requalified by inclusion criteria and eligible to participate in a crossover study to receive
thermal therapy. There were no unanticipated adverse device effects or reports of de novo erectile
dysfunction, rectal wall injury, or fistula. Fifty-seven percent of the Treatment and Crossover
subjects did not report any procedure or device related AEs. Eighty percent of the adverse events
reported occurred within the first 30 days post-procedure and were typically of short duration.
There was a total of 6 procedure and/or device related Serious Adverse Events (SAE) reported in a
total of 4 Treatment and Crossover subjects. One subject experienced extended urinary retention
due to untreated intravesical lobe protrusion. A second subject had an allergic reaction to Xanax
and was admitted to the hospital for nausea and vomiting. A third subject experienced bladder neck
contracture and bladder calculi, which resolved within 30 days. A fourth subject was diagnosed
with urosepsis following cystoscopy, which resolved with medication.
As of February 9, 2019, 89% of the adverse events have resolved. The remaining ongoing events
listed will be assessed at the patients’ next clinical study follow up visits. Events will be updated
annually out to five years.
Table 3. All Adjudicated Procedure and/or Device Related AEs for Treatment and Crossover
Subjects Through 4 Year Follow-up.
All Adjudicated Procedure and/or Device Related AEs for Treatment and Crossover
Subjects Through 4 Year Follow-up Percentage of Subjects
Adverse Event
Procedure
or Device
Related
AEs
Severity
Resolved
AEs
Mild
Moderate Severe
Dysuria
17%
14%
4%
0%
97%
Hematuria, Gross
12%
11%
1%
0%
100%
Hematospermia
6%
6%
< 1%
0%
100%
Urinary Frequency
6%
5%
1%
0%
82%
Decrease in Ejaculatory Volume
5%
4%
< 1%
0%
33%
UTI, Suspected
5%
4%
1%
0%
100%
Urinary Retention
5%
< 1%
4%
< 1%
100%
Urinary Urgency
5%
3%
2%
0%
78%
Anejaculation
3%
2%
< 1%
0%
0%
Terminal Dribbling
3%
2%
< 1%
0%
60%
UTI, Culture Proven
3%
1%
2%
0%
100%
Epididymitis
2%
< 1%
2%
0%
100%
Erectile Dysfunction, Worsening
2%
2%
< 1%
0%
0%
Gross Hematuria with Clots
2%
1%
< 1%
0%
100%
Hematuria, Intermittent
uncomplicated
2%
1%
< 1%
0%
100%
Incomplete Voiding
2%
< 1%
1%
0%
100%
Pain/Discomfort with Ejaculation
2%
0%
2%
0%
100%
Pain/Discomfort, Pelvic
2%
1%
< 1%
< 1%
100%
Pain/Discomfort, Penile
2%
2%
0%
0%
100%
Poor Stream
2%
2%
0%
0%
100%
Prostatitis
2%
1%
1%
0%
100%
Splayed Stream
2%
< 1%
1%
0%
100%
Urethral Stricture
2%
0%
2%
0%
100%
Gross Hematuria with retention
1%
0%
1%
0%
100%
Hematuria, Micro
1%
1%
0%
0%
100%
Urinary Incontinence, Urge
1%
< 1%
< 1%
0%
100%
Urinary Tract Infection (UTI)
1%
1%
0%
0%
100%
Total
43%
36%
21%
2%
89%
The following events were reported in < 1% of subjects and were mild or moderate in severity
unless otherwise indicated: anxiety, bladder neck contracture (severe), bladder stone formation
(severe), catheter malfunction, decrease in orgasm pleasure, delay in healing, fever, hesitancy,
irritative voiding symptoms, nausea, pain/discomfort (right testicle, abdomen, leg, other, perineum),
prostate perforation, phlebitis of arm, prostatic calculi, pyuria, retrograde ejaculation, urosepsis
following cystoscopy (severe), shingles on left lower thigh, urethral injury, urinary incontinence
(mixed, stress (resolved)), vomiting, hypotension.
Other Potential Adverse Events
The following adverse events have not been reported in these clinical trials: de novo erectile
dysfunction, pelvic abscess, rectal wall injury, and fistula. Delivering a form of thermal therapy or
misuse of the device has the potential for producing these adverse effects.
Pain Management
The clinical study did not require specific medications to be used and investigators were instructed
to use their clinical judgment in determining what medications, if any, to use on a subject-by-
subject basis. Of the 196 subjects treated in the study 135 (69%) received oral sedation, 41 (21%)
received a prostate block, and 20 (10%) received IV sedation.
Table 4. Types of Medication Used.
Types of Medication
# of Subjects (N=196)
Percentage of Subjects
Oral Pain Medication
135
69%
Prostate Block
41
21%
IV Sedation
20
10%
