Study: NCT02505919

Adverse event: Bladder neck contracture (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 116 at risk

Adverse event: Cardiac (non-procedure-related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 116 at risk

Adverse event: Non-urologic
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 116 at risk

Adverse event: Other bleeding (non-procedure-related)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 116 at risk

Adverse event: Pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Stricture or adhesions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 116 at risk

Adverse event: Urinary tract infection (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 116 at risk

Adverse event: Urinary tract stones (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 116 at risk

Adverse event: Atrial fibrillation (non-procedure-related)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 116 at risk

Adverse event: Bladder neck contracture (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Bladder pain/spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 116 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 116 at risk

Adverse event: Bleeding (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 116 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 116 at risk

Adverse event: Dysuria (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 116 at risk

Adverse event: Erectile Dysfunction (non-procedure-related)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 116 at risk

Adverse event: Hypertension (non-procedure-related)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 116 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 116 at risk

Adverse event: Non-urologic
Serious: no
Organ System: General disorders
Frequency: 16 affected / 116 at risk

Adverse event: Overactive bladder (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 116 at risk

Adverse event: Pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 116 at risk

Adverse event: Pain (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 116 at risk

Adverse event: Penile disorder (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 116 at risk

Adverse event: Prostatitis (non-procedure-related)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Retrograde ejaculation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 116 at risk

Adverse event: Retrograde ejaculation (non-procedure-related)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 116 at risk

Adverse event: Rising PSA (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 116 at risk

Adverse event: Stricture or adhesions
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 116 at risk

Adverse event: Stricture or adhesions (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Urethral damage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 116 at risk

Adverse event: Urinary retention (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 116 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 116 at risk

Adverse event: Urinary tract infection (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 116 at risk

Adverse event: Urinary tract stones (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 116 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 116 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 116 at risk

Adverse event: Bladder neck contracture (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 65 at risk

Adverse event: Cardiac (non-procedure-related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 65 at risk

Adverse event: Penial infection (non-procedure-related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Prostate cancer (non-procedure-related)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Stricture or adhesions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Stricture or adhesions (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 65 at risk

Adverse event: Urinary retention (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary tract stones (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage (non-procedure-related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Atrial fibrillation (non-procedure-related)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Bladder neck obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Bladder neck contracture (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Bladder pain/spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 65 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 65 at risk

Adverse event: Bleeding (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 65 at risk

Adverse event: Decreased libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 65 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 65 at risk

Adverse event: Dysuria (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 65 at risk

Adverse event: Erectile Dysfunction (non-procedure-related)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 65 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypertension (non-procedure-related)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 65 at risk

Adverse event: Non-urologic
Serious: no
Organ System: General disorders
Frequency: 7 affected / 65 at risk

Adverse event: Pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 65 at risk

Adverse event: Pain (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Perineal swelling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Prostatitis (non-procedure-related)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Retrograde ejaculation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 65 at risk

Adverse event: Retrograde ejaculation (non-procedure-related)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 65 at risk

Adverse event: Rising PSA (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Sexual dysfunction (non-procedure-related)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 65 at risk

Adverse event: Stricture or adhesions
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Stricture or adhesions (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 65 at risk

Adverse event: Swollen Testicles
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urethral damage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 65 at risk

Adverse event: Urinary retention (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 65 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 65 at risk

Adverse event: Urinary tract infection (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 65 at risk

Adverse event: Urinary tract stones (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 65 at risk

Adverse event: Urinary urgency/frequency/difficulty/leakage (non-procedure-related)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 65 at risk