Study: NCT00998790

Adverse event: Urinary Incontinence- Persistent
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 113 at risk

Adverse event: Urinary Incontinence- De Novo Stres
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: De Novo Detrusor Instability
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Infection- Incision Site
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Worsening Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 113 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Urethral perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Difficulty with Erections
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 113 at risk

Adverse event: Other: Syncope/Palpitations/Heart Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 113 at risk

Adverse event: Other: Cardiac Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Carpal Tunnel
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Chest Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Infection, Hernia Mesh
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Other: Infection, Renal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Other: Infection, Septicemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Other: Intestinal Hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Ischemia, Femoral
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Respiratory Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Sub-Occlusive Syndrome, Femoral
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Varices
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 113 at risk

Adverse event: Pain/Disconfort
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 113 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 113 at risk

Adverse event: Urinary Incontinence- De Novo Stress
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 113 at risk

Adverse event: Urinary Incontinence- De Novo Urge
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 113 at risk

Adverse event: Urinary Track Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 113 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 113 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 113 at risk

Adverse event: De Novo Detrusor Instability
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Urinary Incontinence- Persistent
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Post micturition dribble
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Difficulty With Erections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Worsening Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 113 at risk

Adverse event: Other: Constipation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 113 at risk

Adverse event: Other: Catheter could not be replaced
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Other: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 113 at risk

Adverse event: Other: Blood Clots
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Coagulation at the praeputium and glans
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Post Void Blood Loss
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other Pruritis and Swelling of Genitalia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other Scrotal Hematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Scrotal Numbness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Scrotal Sensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Urethral Pains
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Vein Perforation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 113 at risk

Adverse event: Other: Prostate Cancer
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 113 at risk

Adverse event: Other: Syncope/Palpitations/Heart Block
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 113 at risk

Adverse event: Other: Abdominal Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Bacterial Infection on Penis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Balanitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Dry Mouth
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Foreskin Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Other: Fungal Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Other: General Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Hemorrhagic Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Hemorrhoids
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Inflammation of Penis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Itching in Pubis Area
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Lymph Node Swelling
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Parotiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Peripheral Edema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Respiratory Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Rheumatoid Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Stress Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Stricture
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Thyroid Lump
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Urge Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Other: Wound Inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk