Study: NCT03605745

Adverse event: Prostatitis
Serious: yes
Organ System: Infections and infestations
Notes: Acute Prostatitis
Frequency: 1 affected / 47 at risk

Adverse event: Hematuria Gross with Clots & Retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Bells Palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Worsening of Right Inguinal Hernia
Frequency: 1 affected / 47 at risk

Adverse event: UTI - Culture Proven
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 47 at risk

Adverse event: Hematuria - Gross
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 47 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 47 at risk

Adverse event: Bladder Spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 47 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 47 at risk

Adverse event: Acute Urinary Retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 47 at risk

Adverse event: Urinary Incontinence - Urge
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 47 at risk

Adverse event: Pain/Discomfort - Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Pain/Discomfort - Penile
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 47 at risk

Adverse event: Poor Stream
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 47 at risk

Adverse event: Terminal dribbling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 47 at risk

Adverse event: Urinary Incontinence - Not Specified
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Erectile Dysfunction - Worsening
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 47 at risk

Adverse event: Ejaculation failure
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 47 at risk

Adverse event: Decrease in Ejaculatory Volume
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 47 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 47 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 47 at risk

Adverse event: Incomplete Voiding
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 47 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 47 at risk

Adverse event: Catheter Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 47 at risk

Adverse event: Erectile Dysfunction - De Novo
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hematuria - Intermittent Uncomplicated
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hematuria Gross with Clots & Retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain/Discomfort - Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain/Discomfort - Pelvic
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain/Discomfort - Suprapubic
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Retrograde Ejaculation - Confirmed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk