Study: NCT01686958

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Notes: Patient diagnosed with epididymitis on left side, requiring antibiotics. Shortly thereafter patient developed a fever requiring hospital admission with changes to prescribed antibiotics.
Frequency: 1 affected / 30 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: After removal of suprapubic catheter (SPC) as per protocol, the patient experienced retention and received an urethral catheter, but he continued experiencing retention, hence was hospitalized \& required a second SPC.
Frequency: 1 affected / 30 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 30 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 30 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 30 at risk

Adverse event: Urinary stricture
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fecal straining
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bladder irritation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 30 at risk

Adverse event: Edema: penile and/or scrotal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 30 at risk

Adverse event: Edema: testicular
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increased post void urinary residual in bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Obstructive micturition
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 30 at risk

Adverse event: Penile discharge or bleeding
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 30 at risk

Adverse event: Prostate anatomical change or discoloration
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 30 at risk

Adverse event: Prostate inflammation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Prostate tissue sloughing
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Scarred urethra
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urethral skin tags
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 30 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 30 at risk

Adverse event: Urinary sensation to void
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 30 at risk

Adverse event: Urine abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Erectile dysfunction or worsening erectile function
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 30 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 30 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 30 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ear drainage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Hematoma or Ecchymosis: Buttock
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemtoma or Ecchymosis: Femur
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hematoma or Ecchymosis: Sacral bone
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Patient movement at onset of treatment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Raised lump: Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 30 at risk

Adverse event: Pain: Back, hips, shoulder, upon catheter removal
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pain: Bladder, penile, perineal, prostate, urethral
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 30 at risk

Adverse event: Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk