## Protocol Section
### Identification Module
**NCT ID:** NCT03423979

**Acronym:** EVEREST-I

**Brief Title:** Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

**Official Title:** Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

#### Organization Study ID Info
**ID:** PR1051
#### Organization
**Class:** INDUSTRY
**Full Name:** Urotronic Inc.
### Status Module
#### Completion Date
**Date:** 2024-03-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2019-06-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-07-03

**Type:** ACTUAL

**Results First Submit Date:** 2023-05-10

**Results First Submit QC Date:** 2023-06-14

#### Start Date
**Date:** 2017-12-19

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2018-02-06
**Type:** ACTUAL
**Study First Submit Date:** 2018-01-30
**Study First Submit QC Date:** 2018-02-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Urotronic Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.

The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

**Detailed Description:** A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first.

Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.

Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.

### Conditions Module

**Conditions:**

- Benign Prostatic Hyperplasia

- Benign Prostatic Hypertrophy

**Keywords:**

- BPH

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Optilume™ BPH Prostatic DCB treatment procedure

**Intervention Names:**

- Device: Optilume™ BPH Prostatic DCB Dilation Catheter

- Drug: Paclitaxel

**Label:** Optilume™ BPH Prostatic DCB Dilation Catheter

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Optilume™ BPH Prostatic DCB Dilation Catheter

**Description:** BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

**Name:** Optilume™ BPH Prostatic DCB Dilation Catheter

**Other Names:**

- BPH Prostatic DCB

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Optilume™ BPH Prostatic DCB Dilation Catheter

**Description:** paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

**Name:** Paclitaxel

**Other Names:**

- drug coated balloon

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.

**Measure:** Therapeutic Responder at 3 Months

**Time Frame:** 90 days

**Description:** The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.

**Measure:** Major Device/Procedure Related Complications

**Time Frame:** 90 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male subject \> 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
4. Post-void residual (PVR) ≤ 250 ml
5. Prostate volume 20 - 80 gm as determined by TRUS
6. Prostatic urethra length is 35 - 55 mm as determined by TRUS
7. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

1. Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
3. Presence of a penile implant or stent(s) in the urethra or prostate
4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
5. PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
6. Confirmed or suspected malignancy of prostate or bladder
7. Active or history of epididymitis within the past 3 months
8. Previous pelvic irradiation or radical pelvic surgery
9. Documented active urinary tract infection (UTI) 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 catheterization specimen)
10. Visible hematuria with subject urine sample without known contributing factor
11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
12. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)
14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment
16. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
17. Post-void residual volume \> 250 ml or catheter dependent bladder drainage
18. Overactive bladder (OAB) or urge incontinence
19. Known poor detrusor muscle function (e.g. Qmax \< 5 ml/sec)
20. Current bladder stones or prostatic calculi
21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure
22. History of cancer in non-genitourinary system which 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
23. History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion
24. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
25. Expected life expectancy \< one year
26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
27. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study
28. In the opinion of the investigator, it is not in the subject's best interest to participate in the study
29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel)
30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study
31. Device that corresponds with the subject's prostate size per the IFU is not available
32. Intravesical prostatic protrusion (IPP) \> 1 cm
33. Current uncontrolled diabetes (hemoglobin A1c \> 7%)
34. Unable or unwilling to provide all the protocol-required semen samples
35. Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel

**Gender Based:** True

**Gender Description:** Based on biological sex

**Minimum Age:** 50 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Santiago De Los Caballeros

**Country:** Dominican Republic

**Facility:** Union Medica Hospital

**State:** Santiago

**Location 2:**

**City:** Santo Domingo Oeste

**Country:** Dominican Republic

**Facility:** Urolaser SRL

**State:** Santo Domingo

**Location 3:**

**City:** La Romana

**Country:** Dominican Republic

**Facility:** Centro Medico Dr. Canela, SRL

**Location 4:**

**City:** Panama City,

**Country:** Panama

**Facility:** Consultorios Royal Center

**State:** Urbanización Marbella Ciudad De Panamá

**Location 5:**

**City:** Ciudad de Panamá

**Country:** Panama

**Facility:** Centro Especializado San Fernando

#### Overall Officials

**Official 1:**

**Affiliation:** Urotronic Inc.

**Name:** Jill Moland

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-03-25

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 2744200

- Type Abbrev: Prot

- Upload Date: 2023-06-14T16:39

- Date: 2018-07-19

- Filename: SAP_002.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 295705

- Type Abbrev: SAP

- Upload Date: 2023-06-14T16:40

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M14334

- Name: Prostatic Hyperplasia

- Relevance: HIGH

- As Found: Prostatic Hyperplasia

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophy

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M7292

- Name: Dilatation, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011470

- Term: Prostatic Hyperplasia

- ID: D000006965

- Term: Hyperplasia

- ID: D000006984

- Term: Hypertrophy

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-06-07

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Optilume™ BPH Prostatic DCB Dilation Catheter

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 80

**Description:** Optilume™ BPH Prostatic DCB treatment procedure

Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

**ID:** EG000

**Other Num Affected:** 43

**Other Num at Risk:** 80

**Serious Number Affected:** 22

**Serious Number At Risk:** 80

**Title:** Optilume™ BPH Prostatic DCB Dilation Catheter

**Frequency Threshold:** 5

#### Other Events

**Term:** Hematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

**Term:** Urinary Retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

**Term:** Urinary Incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

**Term:** Ejaculation Disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 21.1

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 21.1

#### Serious Events

**Term:** Urinary Incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 80

**Num Events:** 2

**Term:** Hematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 80

**Num Events:** 7

**Term:** Urethral Stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 80

**Num Events:** 4

**Term:** Urinary Retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Cerebrovascular Accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 80

**Num Events:** 2

**Term:** Anesthetic Complication (Pulmonary)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Complication of Device Removal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Stress Urinary Incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Intervertebral Disc Protrusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Intestinal Obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Urethral Perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Rectal Perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** COVID-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Time Frame:** 3 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 80

**Units:** Participants

### Group

**ID:** BG000

**Title:** Optilume™ BPH Prostatic DCB Dilation Catheter

**Description:** Optilume™ BPH Prostatic DCB treatment procedure

Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.8

**Value:** 65.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 80

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Category Title:** Black/African Origin

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 68

**Category Title:** Hispanic/Latino

**Class Title:** Race/Ethnicity

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.2

**Value:** 35.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Prostate Volume (g)
**Unit of Measure:** grams
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Presence of Intravesical Prostatic Protrusion
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Interim review of safety data lead to refinement of device sizing and appropriate device size selection based on prostate dimensions for the final 30 subjects enrolled. Safety information reported for full cohort, as no pre-specified sub-analyses were planned.
### Point of Contact
**Email:** info@urotronic.com
**Organization:** Urotronic, Inc
**Phone:** (763) 285-7489
**Title:** Vice President of Clinical Affairs
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** In the primary analysis, a worst-case approach was used where those missing 3 month IPSS scores were imputed as non-responders
**Reporting Status:** POSTED
**Time Frame:** 90 days
**Title:** Therapeutic Responder at 3 Months
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Optilume™ BPH Prostatic DCB treatment procedure

Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
**ID:** OG000
**Title:** Optilume™ BPH Prostatic DCB Dilation Catheter
#### Outcome Measure 2
**Description:** The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 90 days
**Title:** Major Device/Procedure Related Complications
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Optilume™ BPH Prostatic DCB treatment procedure

Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
**ID:** OG000
**Title:** Optilume™ BPH Prostatic DCB Dilation Catheter
### Participant Flow Module
#### Group
**Description:** Optilume™ BPH Prostatic DCB treatment procedure

Optilume™ BPH Prostatic DCB Dilation Catheter: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Paclitaxel: paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
**ID:** FG000
**Title:** Optilume™ BPH Prostatic DCB Dilation Catheter
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 80
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 79
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Has Results:** True